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Notice2022-00955

AARRIC, Inc. d/b/a at Cost RX; Decision and Order

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Published

January 19, 2022

Issuing agencies

Justice DepartmentDrug Enforcement Administration

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<title>Federal Register, Volume 87 Issue 12 (Wednesday, January 19, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Pages 2905-2936]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00955]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 20-08]

AARRIC, Inc. d/b/a at Cost RX; Decision and Order

On January 3, 2020, a former Acting Administrator of the Drug
Enforcement Administration (hereinafter, DEA or Government), issued an
Order to Show Cause and Immediate Suspension of Registration
(hereinafter, OSC) to AARRIC, Inc. d/b/a AT COST RX (hereinafter,
Respondent). Administrative Law Judge Exhibit (hereinafter, ALJ Ex.) 1,
(OSC) at 1. The OSC/ISO informed Respondent of the immediate suspension
of its DEA Certificate of Registration Number FA2125640 (hereinafter,
registration or COR) and proposed its revocation, the denial of any
pending applications for renewal or modification of such registration,
and the denial of any pending applications for additional DEA
registrations pursuant to 21 U.S.C. 824(a)(4) and 823(f), because
Respondent's ``continued registration is inconsistent with the public
interest.'' Id. (citing 21 U.S.C. 824(a)(4) and 823(f)).
In response to the OSC, Respondent timely requested a hearing
before an Administrative Law Judge. ALJ Ex. 2. The hearing in this
matter was conducted from November 16-20, 2020, at the DEA Hearing
Facility in Arlington, Virginia, with the parties and their witnesses
participating through video-teleconference.*\A\ On April 7, 2021, Chief
Administrative Law Judge John J. Mulrooney, II (hereinafter, Chief ALJ)
issued his Recommended Rulings, Findings of Fact, Conclusions of Law
and Decision (hereinafter, Recommended Decision or RD). On

[[Page 2906]]

December 15, 2020, the Government and Respondent filed exceptions to
the Recommended Decision (hereinafter, Gov Exceptions and Resp
Exceptions, respectively). Having reviewed the entire record, I find
Respondent's Exceptions without merit and I adopt the ALJ's Recommended
Decision with minor modifications, as noted herein. I have addressed
each of Respondent's Exceptions and I issue my final Order in this case
following the Recommended Decision.
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*\A\ [This footnote has been relocated from RD n.5.] At all
times prior to and during the hearing, the Respondent was
represented by multiple, able counsel. The Respondent's (then)
counsels raised no issue during the proceedings or in the
Respondent's closing brief regarding the fairness of the
proceedings. The day after its closing brief was filed, the
Respondent sought to discharge its lawyers and opted to have itself
represented by its (non-lawyer) owner. ALJ Ex. 56. Acting as a non-
attorney representative (see 21 CFR 1316.50), the Respondent's owner
moved to disqualify the Government's expert and to recuse me [the
Chief ALJ]. ALJ Exs. 57, 58, 61. These motions have been disposed of
in separate orders issued contemporaneously with this recommended
decision. ALJ Exs. 67, 68. A joint motion to be excused from further
representation of the Respondent (ALJ Ex. 60) filed by his lawyers
(at the request of the tribunal) was granted for the reasons stated
therein. ALJ Ex. 62.
[I agree with the Chief ALJ's procedural rulings in this case,
including his dismissal of Respondent's two recusal motions. In
these motions, Respondent argued that the Chief ALJ ``den[ied]
Respondent [the] right to a fair trial'' by ``creat[ing] an
atmosphere of prejudice and lack of impartiality.'' ALJ Ex. 57, at
3. Respondent further argued that the Chief ALJ ``morphed [the
Government's case] into a plausible case'' by ``w[earing] the hat of
the Government's lawyer during most of the witness examination.''
Id. at 2. Respondent's motions reference portions of the record
where the Chief ALJ assisted the Government in authenticating
documents and questioning its witnesses. Although Respondent
acknowledged that ALJs are permitted to question witnesses,
Respondent argues that the Chief ALJ used his questioning authority
to buttress the Government's case and ``patch[ ] up areas where
there were obvious gaps in the Government's case,'' while not
``provid[ing] the same helping hand to Respondent when Respondent
was attempting to authenticate documents that Respondent believes
were critical to its defense. Id. at 5, 10. Additionally, Respondent
alleged that it was inappropriate for the Chief ALJ to ask
Respondent's representative, Dr. Howard, whether he agreed with
certain testimony by Respondent's expert, because it ``placed . . .
Dr. Howard in an awkward position to have to incriminate his own
expert just to appease the ALJ.'' Id. at 26, 30.
I find that Respondent's recusal motions are without merit. As
the Chief ALJ stated in his neutral and carefully-reasoned dismissal
order, Respondent--the proponent of the recusal motion--has the
burden of demonstrating that the Chief ALJ exhibited a ``deep-seated
favoritism or antagonism that would make fair judgment impossible.''
Order Denying the Respondent's Recusal Motions, at 6. Respondent did
not identify any evidence of favoritism or antagonism, much less the
type of deep-seated favoritism or antagonism that would make fair
judgment impossible. Rather, Respondent identified instances where
the Chief ALJ was exercising his discretionary authority to regulate
the hearing, by asking clarifying questions of counsel and witnesses
and issuing evidentiary rulings. See Order, at 7 (citing 5 U.S.C.
556(c)(5); 21 CFR 1316.52(e)). Courts have uniformly held that
judicial rulings issued during the course of litigation rarely
constitute evidence of cognizable bias. Id. (citing Liteky v. United
States, 510 U.S. 540, 555 (1994), Hamm v. Members of Bd. of Regents,
708 F.2d 647, 651 (11th Cir. 1983), Dewey C. Mackay, M.D., 75 FR
49,956, 49,958-59 (2010)). Additionally, as the Chief ALJ
highlighted in his dismissal order, the Chief ALJ frequently
clarified the record for Respondent's benefit and overwhelmingly
issued evidentiary rulings in Respondent's favor. Id. at 8-9.
Furthermore, Respondent's recusal motions were untimely, which is an
independent basis for their dismissal. Id. at 7, 15-16.
Beyond the substantive and procedural defects of Respondent's
recusal motions, the motions convey a contemptuous tone towards the
Chief ALJ, which supports my decision that Respondent's registration
is inconsistent with the public interest. Respondent was
particularly outraged that the Chief ALJ questioned Respondent's
representative about whether he agreed with the Respondent's
expert's expressions of hostility towards DEA as a regulator. Based
on Respondent's attitude towards DEA and the Chief ALJ, I find it
unlikely that Respondent would modify its behavior and become a law-
abiding, cooperative registrant. Certainly, Respondent's focus on
repudiating the Chief ALJ rather than acknowledging its own
misconduct shows that it falls far short of the ``true remorse''
that is required when a registrant has committed acts that are
inconsistent with the public interest. Michael S. Moore, M.D., 76 FR
45,867, 45,877 (2011).
For the same reasons stated above, I find that Respondent's
Exceptions to ALJ's Denial of Respondent's Motions for Recusal and
Request for Expedited Ruling on the Order Denying Recusal are
without merit. ALJ Ex. 69 (dated April 27, 2021).]
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Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge *B 1 2 3
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*\B\ I have omitted the RD's discussion of the procedural
history to avoid repetition with my introduction.
\1\ [Footnote relocated, see infra n. *M.]
\2\ [Footnote relocated, see supra n.*A.]
\3\ [Omitted for brevity.]
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After carefully considering the testimony elicited at the hearing,
the admitted exhibits, the arguments of counsel, and the record as a
whole, I have set forth my recommended findings of fact and conclusions
of law below.

The Allegations

The Government alleges that the Respondent Pharmacy's COR should be
revoked because on numerous occasions between February 2018 and
September 2019, it repeatedly dispensed prescriptions to ten patients
(collectively, the Ten Patients) \4\ without addressing or resolving
factual indicia (i.e., ``red flags'') of potential drug diversion and
in contravention of its corresponding responsibility to ensure the
prescriptions were issued for a legitimate medical purpose. ALJ Ex. 1
at 2.
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\4\ In this recommended decision, initials have been substituted
for the names of the Respondent's customer-patients to preserve
their personally identifiable information. The Ten Patients include
Patients JA, EA, SD, LH, DH, DK, JM, ST, JW, and CW.
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The Evidence

The Stipulations

The parties entered into factual stipulations prior to the
litigation of this matter, which were accepted by the tribunal.\5\ By
virtue of those stipulations, the following factual matters are deemed
conclusively established in this case:
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\5\ ALJ Ex. 38.
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1. The Respondent is registered with DEA to handle controlled
substances in Schedules II through V under DEA COR No. FA2125640 at
16970 San Carlos Boulevard, Suite 110, Fort Myers, Florida 33908.
2. DEA COR No. FA2125640 will expire by its own terms on June 30,
2022.
3. DEA lists Adderall (amphetamine-dextroamphetamine mixture) as a
Schedule II controlled substance under 21 CFR 1308.12(d)(1).
4. DEA lists Ambien (zolpidem tartrate) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(57).\6\
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\6\ Multiple incorrect citations set forth in the proposed
stipulations propounded by the parties have been corrected in this
RD to reflect the current regulatory designation.
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5. DEA lists Ativan (lorazepam) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(32).
6. DEA lists hydromorphone as a Schedule II controlled substance
under 21 CFR 1308.12(b)(1)(vii).
7. DEA lists Klonopin (clonazepam) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(12).
8. DEA lists methadone as a Schedule II controlled substance under
21 CFR 1308.12(c)(15).
9. DEA lists MS Contin (morphine sulfate extended release) as a
Schedule II controlled substance under 21 CFR 1308.12(b)(1)(ix).
10. DEA lists Norco (hydrocodone-acetaminophen) as a Schedule II
controlled substance under 21 CFR 1308.12(b)(1)(vi).
11. DEA lists oxycodone as a Schedule II controlled substance under
21 CFR 1308.12(b)(1)(xiv).
12. DEA lists Percocet (oxycodone-acetaminophen) as a Schedule II
controlled substance under 21 CFR 1308.12(b)(1)(xiv).
13. DEA lists Restoril (temazepam) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(53).
14. DEA lists Soma (carisoprodol) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(7).
15. DEA lists Valium (diazepam) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(17).
16. DEA lists Xanax (alprazolam) as a Schedule IV controlled
substance under 21 CFR 1308.14(c)(2).
17. Between February 19, 2018, and at least September 2, 2019, the
Respondent filled at least 21 prescriptions for Patient JA for 90-120
units of hydromorphone 8 mg. These prescriptions were filled on or
about the following specific occasions:

----------------------------------------------------------------------------------------------------------------
Fill date Drug dispensed Prescription No.
----------------------------------------------------------------------------------------------------------------
2/19/2018...................................... 112 units of hydromorphone 8 mg....... 535081
3/19/2018...................................... 112 units of hydromorphone 8 mg....... 535597
4/16/2018...................................... 120 units of hydromorphone 8 mg....... 536108
5/14/2018...................................... 120 units of hydromorphone 8 mg....... 536635
6/11/2018...................................... 120 units of hydromorphone 8 mg....... 537027
7/10/2018...................................... 120 units of hydromorphone 8 mg....... 537292
8/7/2018....................................... 120 units of hydromorphone 8 mg....... 537539
9/4/2018....................................... 120 units of hydromorphone 8 mg....... 537922
10/2/2018...................................... 120 units of hydromorphone 8 mg....... 538321
10/30/2018..................................... 120 units of hydromorphone 8 mg....... 538758
11/26/2018..................................... 120 units of hydromorphone 8 mg....... 539235
12/21/2018..................................... 120 units of hydromorphone 8 mg....... 539671
1/21/2019...................................... 120 units of hydromorphone 8 mg....... 540097
2/18/2019...................................... 120 units of hydromorphone 8 mg....... 540569
3/18/2019...................................... 120 units of hydromorphone 8 mg....... 541028
4/15/2019...................................... 120 units of hydromorphone 8 mg....... 541503
5/13/2019...................................... 105 units of hydromorphone 8 mg....... 541983
6/10/2019...................................... 90 units of hydromorphone 8 mg........ 542444
7/8/2019....................................... 90 units of hydromorphone 8 mg........ 542892
8/5/2019....................................... 90 units of hydromorphone 8 mg........ 543372
9/2/2019....................................... 90 units of hydromorphone 8 mg........ 543802
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[[Page 2907]]

18. Patient JA paid cash for all of the above-listed prescriptions
for controlled substances that he filled with the Respondent.
19. Between September 19, 2018, and at least September 16, 2019,
the Respondent filled at least 42 prescriptions for Patient EA for 28
units of MS Contin 30 mg, 120 units of oxycodone 30 mg, and 30 units of
Xanax 1 mg. These prescriptions were filled on or about the following
specific occasions:

20. Patient EA paid cash for all of the above-listed prescriptions
for controlled substances that he filled with the Respondent.
21. Between February 20, 2018, and at least September 4, 2019, the
Respondent filled at least 56 prescriptions for Patient SD for 21-30
units of MS Contin 30 mg, 60 units of MS Contin 60 mg, 92-135 units of
oxycodone 30 mg, 30 units of Xanax 0.5 mg, and 30 units of Xanax 1 mg.
These prescriptions were filled on or about the following specific
occasions:

22. Patient SD paid cash for all of the above-listed prescriptions
for controlled substances that he filled with the Respondent on or
after April 16, 2018.
23. Between March 6, 2018, and at least September 11, 2019, the
Respondent filled at least 34 prescriptions for Patient LH for 28-60
units of MS Contin 30 mg and 120-140 units of oxycodone 30 mg. These
prescriptions were filled on or about the following specific occasions:

[[Page 2908]]

5/22/2019........................ 28 units of MS Contin 30 mg; and 542196-542197
120 units of oxycodone 30 mg.
6/19/2019........................ 28 units of MS Contin 30 mg; and 542646-542647
120 units of oxycodone 30 mg.
7/17/2019........................ 28 units of MS Contin 30 mg; and 543112-543113
120 units of oxycodone 30 mg.
8/14/2019........................ 28 units of MS Contin 30 mg; and 543557-543558
120 units of oxycodone 30 mg.
9/11/2019........................ 28 units of MS Contin 30 mg; and 543979; 543982
120 units of oxycodone 30 mg.
----------------------------------------------------------------------------------------------------------------

24. Patient LH paid cash for all of the above-listed prescriptions
for controlled substances that he filled with the Respondent.
25. Between March 8, 2018, and at least September 11, 2019, the
Respondent filled at least 59 prescriptions for Patient DH for 60 units
of MS Contin 30 mg, 120 units of hydromorphone 8 mg, and 60 units of
Xanax 2 mg. These prescriptions were filled on or about the following
specific occasions:

----------------------------------------------------------------------------------------------------------------
Fill date Drug(s) dispensed Prescription Nos.
----------------------------------------------------------------------------------------------------------------
3/8/2018......................... 60 units of MS Contin 30 mg..... 535478
3/13/2018........................ 120 units of hydromorphone 8 mg; 535525-535526
and 60 units of Xanax 2 mg.
4/10/2018........................ 60 units of MS Contin 30 mg; 120 536047; 536050; 536053
units of hydromorphone 8 mg;
and 60 units of Xanax 2 mg.
5/8/2018......................... 60 units of MS Contin 30 mg; 120 536566-536567; 536571
units of hydromorphone 8 mg;
and 60 units of Xanax 2 mg.
6/5/2018......................... 120 units of hydromorphone 8 mg; 536993-536994
and 60 units of Xanax 2 mg.
6/15/2018........................ 60 units of MS Contin 30 mg..... 537081
7/4/2018......................... 120 units of hydromorphone 8 mg; 537254; 537257
and 60 units of Xanax 2 mg.
7/13/2018........................ 60 units of MS Contin 30 mg..... 537339
7/31/2018........................ 120 units of hydromorphone 8 mg; 537486; 537489
and 60 units of Xanax 2 mg.
8/28/2018........................ 120 units of hydromorphone 8 mg; 537853; 537857
and 60 units of Xanax 2 mg.
8/31/2018........................ 60 units of MS Contin 30 mg..... 537906
9/25/2018........................ 120 units of hydromorphone 8 mg; 538255; 538258
and 60 units of Xanax 2 mg.
10/5/2018........................ 60 units of MS Contin 30 mg..... 538386
10/23/2018....................... 120 units of hydromorphone 8 mg; 538663; 538666
and 60 units of Xanax 2 mg.
11/2/2018........................ 60 units of MS Contin 30 mg..... 538879
11/20/2018....................... 120 units of hydromorphone 8 mg; 539162; 539165
and 60 units of Xanax 2 mg.
12/3/2018........................ 60 units of MS Contin 30 mg..... 539350
12/18/2018....................... 120 units of hydromorphone 8 mg; 539596; 539599
and 60 units of Xanax 2 mg.
12/31/2018....................... 60 units of MS Contin 30 mg..... 539743
1/15/2019........................ 120 units of hydromorphone 8 mg; 540031; 540035
and 60 units of Xanax 2 mg.
1/28/2019........................ 60 units of MS Contin 30 mg..... 540191
2/12/2019........................ 120 units of hydromorphone 8 mg; 540467; 540473
and 60 units of Xanax 2 mg.
2/25/2019........................ 60 units of MS Contin 30 mg..... 540670
3/11/2019........................ 120 units of hydromorphone 8 mg; 540938-540939
and 60 units of Xanax 2 mg.
3/25/2019........................ 60 units of MS Contin 30 mg..... 541179
4/8/2019......................... 120 units of hydromorphone 8 mg; 541428-541429
and 60 units of Xanax 2 mg.
4/22/2019........................ 60 units of MS Contin 30 mg..... 541661
5/6/2019......................... 120 units of hydromorphone 8 mg; 541914-541915
and 60 units of Xanax 2 mg.
5/20/2019........................ 60 units of MS Contin 30 mg..... 542133
6/3/2019......................... 120 units of hydromorphone 8 mg; 542349; 542358
and 60 units of Xanax 2 mg.
6/17/2019........................ 60 units of MS Contin 30 mg..... 542587
7/1/2019......................... 120 units of hydromorphone 8 mg; 542839-542840
and 60 units of Xanax 2 mg.
7/15/2019........................ 60 units of MS Contin 30 mg..... 543059
7/29/2019........................ 120 units of hydromorphone 8 mg; 543275-543276
and 60 units of Xanax 2 mg.
8/12/2019........................ 60 units of MS Contin 30 mg..... 543489
8/26/2019........................ 120 units of hydromorphone 8 mg; 543703-543704
and 60 units of Xanax 2 mg.
9/11/2019........................ 60 units of MS Contin 30 mg..... 543975
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26. Patient DH paid cash for all of the above-listed prescriptions
for controlled substances that he filled with the Respondent.
27. Between February 16, 2018, and at least September 12, 2019, the
Respondent filled at least 59 prescriptions for Patient DK for 60 units
of MS Contin 30 mg, 60 units of MS Contin 60 mg, 90-120 units of
hydromorphone 8 mg, 90 units of Xanax 0.5 mg, 60 units of Xanax 1 mg,
and 35-60 units of Soma 350 mg. These prescriptions were filled on or
about the following specific occasions:

[[Page 2909]]

7/11/2018........................ 60 units of MS Contin 60 mg; 120 537307-537309
units of hydromorphone 8 mg;
and 60 units of Xanax 1 mg.
8/8/2018......................... 60 units of MS Contin 60 mg; 120 537565-537566; 537568
units of hydromorphone 8 mg;
and 60 units of Xanax 1 mg.
9/18/2018........................ 60 units of MS Contin 60 mg; 120 538219-538221
units of hydromorphone 8 mg;
and 60 units of Xanax 1 mg.
10/17/2018....................... 60 units of MS Contin 60 mg; 120 538548-538550
units of hydromorphone 8 mg;
and 60 units of Xanax 1 mg.
11/16/2018....................... 60 units of MS Contin 60 mg; 120 539113; 539115-539116
units of hydromorphone 8 mg;
and 60 units of Xanax 1 mg.
12/14/2018....................... 60 units of MS Contin 60 mg; 120 539557-539558; 539560
units of hydromorphone 8 mg;
and 60 units of Xanax 1 mg.
1/11/2019........................ 60 units of MS Contin 60 mg; 120 539990-539991; 539993
units of hydromorphone 8 mg;
and 60 units of Xanax 1 mg.
2/13/2019........................ 60 units of MS Contin 60 mg; 120 540509-540510; 540512
units of hydromorphone 8 mg;
and 60 units of Xanax 1 mg.
3/12/2019........................ 60 units of MS Contin 60 mg; 120 540971; 540977-540978
units of hydromorphone 8 mg;
and 60 units of Xanax 1 mg.
4/11/2019........................ 60 units of MS Contin 60 mg; 120 541496; 541498; 541500
units of hydromorphone 8 mg;
and 60 units of Xanax 1 mg.
5/9/2019......................... 60 units of MS Contin 60 mg; 120 541975-541977
units of hydromorphone 8 mg;
and 60 units of Xanax 1 mg.
6/6/2019......................... 60 units of MS Contin 60 mg; 120 542430-542431; 542433
units of hydromorphone 8 mg;
and 60 units of Xanax 1 mg.
7/5/2019......................... 60 units of MS Contin 60 mg; 120 542882-542883; 542889
units of hydromorphone 8 mg;
and 60 units of Xanax 1 mg.
8/13/2019........................ 60 units of MS Contin 30 mg..... 543528
8/30/2019........................ 90 units of hydromorphone 8 mg; 543798; 543800
and 90 units of Xanax 0.5 mg.
9/12/2019........................ 60 units of MS Contin 30 mg..... 544003
----------------------------------------------------------------------------------------------------------------

28. Patient DK paid cash for all of the above-listed prescriptions
for controlled substances that she filled with the Respondent.
29. Between February 28, 2018, and at least September 17, 2019, the
Respondent filled at least 78 prescriptions for Patient JM for 60 units
of MS Contin 30 mg, 120 units of hydromorphone 8 mg, 60 units of
Restoril 15 mg, 30 units of Restoril 30 mg, and 60 units of Xanax 2 mg.
These prescriptions were filled on or about the following specific
occasions:

----------------------------------------------------------------------------------------------------------------
Fill date Drug(s) dispensed Prescription Nos.
----------------------------------------------------------------------------------------------------------------
2/28/2018........................ 30 units of Restoril 30 mg; and 535267; 535269
60 units of Xanax 2 mg.
3/5/2018......................... 120 units of hydromorphone 8 mg. 535393
3/9/2018......................... 60 units of MS Contin 30 mg..... 535492
3/28/2018........................ 30 units of Restoril 30 mg; and 535799-535800
60 units of Xanax 2 mg.
4/2/2018......................... 120 units of hydromorphone 8 mg. 535842
4/9/2018......................... 60 units of MS Contin 30 mg..... 536038
5/1/2018......................... 120 units of hydromorphone 8 mg; 536422; 536424-536425
30 units of Restoril 30 mg; and
60 units of Xanax 2 mg.
5/8/2018......................... 60 units of MS Contin 30 mg..... 536574
5/29/2018........................ 120 units of hydromorphone 8 mg; 536909-536911
30 units of Restoril 30 mg; and
60 units of Xanax 2 mg.
6/4/2018......................... 60 units of MS Contin 30 mg..... 536967
6/26/2018........................ 120 units of hydromorphone 8 mg; 537182-537183; 537189
30 units of Restoril 30 mg; and
60 units of Xanax 2 mg.
7/5/2018......................... 60 units of MS Contin 30 mg..... 537266
7/24/2018........................ 120 units of hydromorphone 8 mg; 537451; 537452; 537455
30 units of Restoril 30 mg; and
60 units of Xanax 2 mg.
8/1/2018......................... 60 units of MS Contin 30 mg..... 537508
8/21/2018........................ 120 units of hydromorphone 8 mg; 537773; 537778-537779
30 units of Restoril 30 mg; and
60 units of Xanax 2 mg.
8/31/2018........................ 60 units of MS Contin 30 mg..... 537909
9/18/2018........................ 120 units of hydromorphone 8 mg; 538160; 538162
and 60 units of Xanax 2 mg.
9/24/2018........................ 30 units of Restoril 30 mg...... 538235
9/28/2018........................ 60 units of MS Contin 30 mg..... 538302
10/17/2018....................... 120 units of hydromorphone 8 mg; 538541; 538543
and 60 units of Xanax 2 mg.
10/26/2018....................... 60 units of MS Contin 30 mg; and 538728; 538730
30 units of Restoril 30 mg.
11/13/2018....................... 120 units of hydromorphone 8 mg; 539024; 539026
and 60 units of Xanax 2 mg.
11/26/2018....................... 60 units of MS Contin 30 mg; and 539245; 539247
30 units of Restoril 30 mg.
1/9/2019......................... 60 units of MS Contin 30 mg; 120 539924-539925; 539927-539928
units of hydromorphone 8 mg; 30
units of Restoril 30 mg; and 60
units of Xanax 2 mg.
2/6/2019......................... 60 units of MS Contin 30 mg; 120 540415; 540417; 540419-540420
units of hydromorphone 8 mg; 30
units of Restoril 30 mg; and 60
units of Xanax 2 mg.
3/7/2019......................... 60 units of MS Contin 30 mg; 120 540900-540903
units of hydromorphone 8 mg; 60
units of Restoril 15 mg; and 60
units of Xanax 2 mg.
4/3/2019......................... 60 units of MS Contin 30 mg; 120 541355-541358
units of hydromorphone 8 mg; 60
units of Restoril 15 mg; and 60
units of Xanax 2 mg.
4/30/2019........................ 120 units of hydromorphone 8 mg; 541815-541816
and 60 units of Xanax 2 mg.
5/3/2019......................... 60 units of MS Contin 30 mg..... 541878
5/28/2019........................ 120 units of hydromorphone 8 mg; 542248-542249; 542252
30 units of Restoril 30 mg; and
60 units of Xanax 2 mg.
5/30/2019........................ 60 units of MS Contin 30 mg..... 542315
6/25/2019........................ 120 units of hydromorphone 8 mg; 542726; 542729
and 60 units of Xanax 2 mg.
6/27/2019........................ 60 units of MS Contin 30 mg..... 542801
7/23/2019........................ 120 units of hydromorphone 8 mg; 543189-543190; 543194
30 units of Restoril 30 mg; and
60 units of Xanax 2 mg.
7/25/2019........................ 60 units of MS Contin 30 mg..... 543238
8/20/2019........................ 120 units of hydromorphone 8 mg; 543628-543630
30 units of Restoril 30 mg; and
60 units of Xanax 2 mg.
8/23/2019........................ 60 units of MS Contin 30 mg..... 543696
9/17/2019........................ 120 units of hydromorphone 8 mg; 544074-544076
30 units of Restoril 30 mg; and
60 units of Xanax 2 mg.
----------------------------------------------------------------------------------------------------------------

[[Page 2910]]

30. Patient JM paid cash for all of the above-listed prescriptions
for controlled substances that she filled with the Respondent.
31. Between March 7, 2018, and at least August 21, 2019, the
Respondent filled at least 40 prescriptions for Patient ST for 60 units
of MS Contin 60 mg and 150 units of oxycodone 30 mg. These
prescriptions were filled on or about the following specific occasions:

32. Patient ST paid cash for all of the above-listed prescriptions
for controlled substances that he filled with the Respondent on or
after April 4, 2018.
33. Between April 19, 2018, and at least May 2, 2019, the
Respondent filled at least 30 prescriptions for Patient JW for 28-90
units of methadone 10 mg, 112-120 units of oxycodone 30 mg, and 30
units of Xanax 1 mg. These prescriptions were filled on or about the
following specific occasions:

34. Patient JW paid cash for all of the above-listed prescriptions
for controlled substances that she filled with the Respondent.
35. Between February 26, 2018, and at least August 28, 2019, the
Respondent filled at least 33 prescriptions for Patient CW for 30 units
of methadone 5 mg, 30-60 units of methadone 10 mg, 90-120 units of
hydromorphone 8 mg, 30 units of Xanax 0.5 mg, 30 units of Xanax 1 mg,
and 90 units of Xanax 2 mg. These prescriptions were filled on or about
the following specific occasions:

[[Page 2911]]

6/4/2019......................... 120 units of hydromorphone 8 mg; 542374-542375
and 30 units of Xanax 1 mg.
7/31/2019........................ 120 units of hydromorphone 8 mg; 543329-543330
and 30 units of Xanax 1 mg.
8/28/2019........................ 120 units of hydromorphone 8 mg; 543773-543774
and 30 units of Xanax 1 mg.
----------------------------------------------------------------------------------------------------------------

36. Patient CW paid cash for all of the above-listed prescriptions
for controlled substances that she filled with the Respondent.

The Government's Case *C
---------------------------------------------------------------------------

*\C\ Throughout the Chief ALJ's description of both the
Government's Case and the Respondent's Case, I have made some minor
adjustments to the wording where noted for brevity and for clarity
and to reflect more of my style. I agree with the Chief ALJ on the
astute points that he made and I have left in the content.
---------------------------------------------------------------------------

In addition to its reliance on the agreed factual stipulations
reached by the parties in this case, the Government presented its case
through the testimony of a DEA Diversion Investigator and an expert
pharmacy witness.

Diversion Investigator

The Government presented the testimony of a DEA Diversion
Investigator (DI). DI testified that, as of the date of the hearing, he
has been a DI for approximately three years and is currently stationed
at the Miami field office. Tr. 19. The investigation that culminated in
the present administrative charges was initiated by DI's predecessor,
DI 2. Tr. 22. Upon DI 2's retirement from DEA, DI assumed
responsibility as the lead DEA investigator on the case and inherited
both open and closed evidence requests, as well as the balance of the
investigative case file. Tr. 22-23. According to DI, the Respondent
became the focus of DEA's attention after an on-site inspection by DEA
in 2015. Tr. 24. DI's testimony was also used to authenticate a number
of Government Exhibits, consisting of documents obtained during the
course of the investigation. Tr. 31, 35, 38, 40-41, 46, 48-49, 62, 65,
67, 76, 79-80, 109-10, 364.
DI presented as an objective regulator and investigator with no
discernable motive to fabricate or exaggerate. As a successor
investigator, he demonstrated candor in teasing out which aspects of
the investigation were initiated/controlled by him, and which aspects
were inherited. Where he was unsure of an answer, he presented a good-
faith effort but made no attempt to supply a convenient contrivance.
The testimony of this witness, viewed in toto, was sufficiently
detailed, plausible, and internally consistent to be afforded full
credibility in this case.

Dr. Tracey Schossow, Pharm.D.

The Government presented the expert testimony of Dr. Tracey
Schossow. Dr. Schossow's curriculum vitae (CV) \7\ reflects that she
received a Doctorate in Pharmacy in 2001, has practiced,\8\ managed,
consulted, trained, and taught pharmacy for twenty-six years in a
variety of settings, and even authored the pharmacy portion of a manual
for a hospice company. Tr. 135, 155; Gov't Ex. 17. In fact, the witness
testified that her introduction to the pharmacy profession commenced
with work as a pharmacy technician in her father's independent pharmacy
back in 1982. Tr. 136.
---------------------------------------------------------------------------

\7\ Gov't Ex. 17.
\8\ Dr. Schossow testified that she has practiced as a clinical
pharmacist and a retail pharmacist. Tr. 145. In her words, ``a
retail pharmacist does most of the actual dispensing of the
medications into the bottles, versus a clinical pharmacist is more
involved with the patient and the doctor, working more closely with
them, usually offering recommendations on managing the patient.''
Id. The witness testified that she practiced retail pharmacy for
about twelve years. Id.
---------------------------------------------------------------------------

In the midst of a largely uneventful presentation, there arose a
bizarre twist of events that bears special mention. During a cross-
examination conducted by the Respondent's (then) counsel, Dr. Schossow
[testified] that she was familiar with the composition of the Florida
Board of Pharmacy, and volunteered that ``It's made up of pharmacists.
I sat on the Board one time so--a long time ago.'' Tr. 455. Since
neither Dr. Schossow's CV,\9\ nor her direct testimony regarding her
qualifications, reflected past employment as a Board member, [this
testimony was unexpected. On cross examination, Respondent's counsel
followed up on this issue with Dr. Schossow, and they had the following
exchange:
---------------------------------------------------------------------------

\9\ Gov't Ex. 17.

Q: I understood you to say that you sat on the Board of Pharmacy
for a period of time? Is that right?
A: When I first graduated from pharmacy school, yes. I was--this
was a long time ago. I don't know if it was--I don't remember the
position, exactly. It wasn't, like,--I wasn't the head of the Board,
or anything like that. But I did sit on the Board in the meetings.
Q: Okay. And did you vote and participate in the process?
A: I participated in the process, but I didn't have any voting--
I didn't do any voting.
Q: Okay. So, what you're talking about is, maybe, internship-
type position with the board of pharmacy?
A: I don't recall the exact title of it. It was not an intern
position. I was a licensed pharmacist at the time.
Q: All right. And so, this was, when? After you received your
initial degree as a registered pharmacist, or during your Pharm D
program?
A: No, it was after I received my initial pharmacy degree back
in '94.

Tr. 546-47. Dr. Schossow then confirmed that she ``wasn't sitting on
the board'' and ``didn't have a title like that,'' but she did
participate. Id. at 547. She continued, ``It was a long time ago, so I
do not recall the official, whatever I was doing at that time.'' Id. As
discussed in more detail below, this testimony was inconsistent and
confusing.
Dr. Schossow also testified that she could not recall particular
sources that she reviewed prior to her testimony in this case, but
stated that she is constantly reviewing a variety of information from
legal sources, federal guidelines, as well as clinical data and studies
to stay current on the applicable standard of care for Florida
pharmacists.\10\ Tr. 152-53, 163; see also id. at 193. Dr. Schossow
also volunteered that she ``also had a lot of patients in the community
arrested for opioid and other controlled substance fraud and abuse.''
\11\ Tr. 137. The witness testified that she has also served as a
pharmacy expert reviewer in federal agency cases involving controlled
substances \12\ and has been recognized as an expert witness on
multiple occasions in administrative enforcement cases. Tr. 145-47. Dr.
Schossow was tendered \13\ and, over the Respondent's

[[Page 2912]]

objection, was accepted as an expert witness in the standard of care
for Florida pharmacists and pharmacy practice in the State of Florida.
Tr. 166-67.
---------------------------------------------------------------------------

\10\ The witness testified that the Florida requirement for
continuing education is limited to one hour every two years. Tr.
197.
\11\ This portion of the witness's testimony was objected to as
irrelevant by the Respondent's counsel, and the tribunal
subsequently sustained the objection. Thus, while no part of this
statement will be considered to the detriment of the Respondent, it
does present some potential insight into the mindset of the
Government's expert. Its consideration is limited to that narrow
point.
\12\ Dr. Schossow testified that she has been compensated for
her professional work as an expert, including by DEA in this case.
Tr. 530. She also testified that although thus far her expert
opinion has been exclusively sought by DEA, she would be willing to
``give [her] opinion to anybody who asks [her] regarding pharmacy.''
Tr. 162-63.
\13\ Tr. 149.
---------------------------------------------------------------------------

According to Dr. Schossow, the applicable standard of care for
dispensing controlled substances in Florida requires a pharmacist to
evaluate every prescription presented by a patient.\14\ Tr. 168-69. Dr.
Schossow encapsulated her view of applicable statutes governing state
corresponding responsibility in Florida as follows:
---------------------------------------------------------------------------

\14\ Throughout her testimony, the witness would refer to
various Florida statutes that, according to her, inform her opinion
on the standard of care for a Florida pharmacist. In evaluating the
role of an expert witness in the pharmacy context, the Agency has
held that a pharmacy expert is ``not [expected to be] an expert in
the details of state law, but she is required as a pharmacist to
understand what conduct is outside of the usual course of
professional practice in her state, whether that is derived from
state law, mandatory training, standards of care or otherwise.''
Suntree Pharmacy, 85 FR 73,753, 73,772 (2020).

[T]he responsibility of a [Florida] pharmacist is to ensure the
safety and efficacy of the therapy for that person and also to
protect that person in regards to safety for the patient and the
---------------------------------------------------------------------------
community. It's very clear.

Tr. 171. Less helpfully, at another point in her testimony, the witness
defined the applicable standard of care as ``[w]hat usually a normal
pharmacist would do in a pharmacy or how they would practice the
profession of pharmacy.'' Tr. 181; see also id. at 336.

According to the Government's expert, in evaluating a prescription,
a Florida pharmacist is required to perform a drug utilization review
(DUR),\15\ which is a process by which a pharmacist analyzes a
prescription to check for red flags signaling a potential diversion
issue, and to ``assure that the prescription is for a legitimate
medical purpose.'' Tr. 169; see id. at 189-90. Dr. Schossow defined a
red flag as ``something on the prescription that alerts the pharmacist
that the prescription may be being diverted or abused and that the
pharmacist must do their due diligence to determine whether that red
flag can be cleared or not.'' Tr. 189-90. When a pharmacist \16\ is
faced with a red flag, the red flag must be addressed and documented.
Tr. 189-90, 198. Documented findings can be recorded on the
prescription itself, within a patient profile, or in a note section of
a pharmacy software program. Tr. 177. The witness opined that a lack of
documentation indicates that the required analysis of a red flag was
not performed by the dispensing pharmacist. Tr. 199-200. The witness
conceded that she did not know whether any of the red flags she
identified were actually analyzed and resolved by the Respondent,\17\
but she made her opinion clear that a deficit in the adequacy of the
documentation setting forth the pharmacist's DUR analysis brings a
dispensing event below the Florida minimum standard of care, and that
the DUR analysis can be set forth on the prescription itself or in a
pharmacy's electronic records. Tr. 177, 740. According to Dr. Schossow,
the mere existence of a red flag, in and of itself, does not always
prohibit a pharmacist from filing a prescription; \18\ it was her view
that upon sufficient documented analysis, all red flags are potentially
resolvable. Tr. 237. The Government's expert clarified early in her
testimony that she was restricting her opinions to the minimum Florida
standard of care, and not elucidating on best practices in the field of
pharmacy. Tr. 175-76.
---------------------------------------------------------------------------

\15\ During her testimony, the witness used the term ``DUR''
interchangeably to mean the process of a drug review, as well as for
a finding made during the review that would warrant further review
(i.e., a red flag); this was confusing and unhelpful. See, e.g., Tr.
187-88.
\16\ It is Dr. Schossow's view that a diversion red flag may
only be resolved by a pharmacist, never a pharmacy technician. Tr.
200.
\17\ Tr. 446.
\18\ Tr. 198.
---------------------------------------------------------------------------

The Government's expert testified that she reviewed prescriptions
and patient profiles corresponding to the Ten Patients \19\ and
determined that dispensing events depicted in those profiles and
records presented numerous red flags, with no documented indications on
the part of the Respondent of any attempts to resolve those red flags
prior to filling the prescriptions in accordance with the standard of
care for a Florida pharmacist. Tr. 431. One such red flag identified by
the witness through the Respondent's paperwork was present in
dispensing events where controlled substances were filled in high-risk
combinations \20\ that significantly elevate the risk for such things
as central nervous system (CNS)/respiratory depression, overdose, coma,
and death. Gov't Exs. 6, 7, 9-11, 13, 14, 22, 23, 25-27, 29; Tr. 215-
16, 218-21; Stip. 33 (Patient JW); Tr. 268-69; Stip. 19 (Patient EA);
Tr. 287-91, 294-95; Stip. 21 (Patient SD); Tr. 309-12; Stip. 25
(Patient DH); \21\ Tr. 321-26; Stip. 27 (Patient DK); \22\ Tr. 330-32;
Stip. 29 (Patient JM); \23\ Tr. 243-45; Stip. 35 (Patient CW).
According to Dr. Schossow, under the Florida standard of care, filling
these prescriptions would require documented indicia that the
pharmacist reviewed the patient's history, reviewed the patient's
information on the Electronic-Florida Online Reporting of Controlled
Substance Evaluation database (E-FORCSE),\24\ spoke with the doctor,
spoke with the prescriber, inquired about the patient treatment plan,
discussed function improvement of the patient, and discussed whether
the patient had been apprised of the associated risks.\25\ Tr. 204,
213-14, 216. The witness explained that there was no indication in the
Respondent's records that the documentation requirement had been
completed or addressed for the high-risk combination red flags that she
identified. Gov't Exs. 6, 7, 9-11, 13-15, 22, 23, 25-27, 29, 32; \26\
Tr. 240-41, 424-25 (Patient JW); Tr. 286, 371-75 (Patient EA); Tr. 295-
300, 375-78 (Patient SD); Tr. 319, 321, 385-88, 397-98, 408-09 (Patient
DH); \27\ Tr. 329-30,

[[Page 2913]]

409-13 (Patient DK); Tr. 346-47, 425-30 (Patient CW). Dr. Schossow's
testimony regarding the absence of documentation also extended to
Patient JM. Tr. 338-39, 413-16, 419-20; Gov't Exs. 11, 15, 27, 32.
However, as highlighted in her testimony, the Respondent's records did
contain notes documenting combination medication discussions between
the pharmacy and Patient JM. Tr. 414-418, 471; Gov't Ex. 32 at 69.
Specifically, the pharmacy notes include, inter alia, the following
entries:
---------------------------------------------------------------------------

\19\ Patients JA, EA, SD, LH, DH, DK, JM, ST, JW, and CW.
\20\ Dr. Schossow identified combinations of opioids and
benzodiazepines that, when taken together, can potentially result in
a dangerous suppression of the central nervous system. Tr. 204.
\21\ Dr. Schossow testified that her opinion would not be
altered by a brief temporal break such as two weeks between the in-
conflict medications. Tr. 318.
\22\ Dr. Schossow testified that her opinion was not altered by
the fact that the prescriptions in conflict were not dispensed on
the same day. Tr. 324.
\23\ Dr. Schossow testified that her opinion was not altered by
the fact that the prescriptions in conflict were dispensed several
days apart. Tr. 338.
\24\ E-FORCSE is the prescription drug monitoring program (PDMP
or PMP) maintained by the State of Florida.
\25\ The Government's expert also referenced guidelines (CDC
Guidelines) issued on March 18, 2016 by the Centers for Disease
Control and Prevention (CDC) regarding morphine equivalent dosages
(MMEs). Tr. 205-06. The CDC Guidelines were the subject of official
notice during the proceedings. ALJ Ex. 39. While the CDC Guidelines
were the subject of some level of pre-hearing notice by the
Government, ALJ Ex. 4 at 23, there was no specific notice that an
MME at any particular level, standing on its own, constitutes a red
flag requiring action by a pharmacy registrant. During her
testimony, Dr. Schossow accepted the proposition that the CDC
Guidelines were issued primarily to guide prescribers, not
pharmacies. Tr. 503-04.
\26\ During the hearing, Proposed Government Exhibit 16 was
initially offered in the form of a compact disc and admitted with
the condition that the Government provide a hard-copy version of the
subset of pages that it seeks to rely upon. ALJ Ex. 44. After the
hearing, the Government discovered that the relevant information
within Proposed Government Exhibit 16 was also contained within
Government Exhibit 32, and subsequently withdrew Proposed Government
Exhibit 16. ALJ Ex. 47.
\27\ Although the Respondent pharmacy's notes did reflect that
its personnel conducted a conversation with the prescriber, the
Government's expert held the view that the documentation was so
lacking in detail that the applicable standard was not met. Tr. 387-
95. Dr. Schossow was steadfast in her opinion that the level of
documentation was wanting, but was unable or unwilling to specify
any sort of a generic standard as to what the level of documentation
needs to be to pass muster. Id.

12/12/19 SPOKE TO MD OFFICE: PT HAS BIPOLAR SCHIZOPHRENIA/ANXIETY.
MD IS AWARE OF COMBO DRUG (XANAX, TEMAZEPAM, HYDRO-MORPHONE,
TIZANIDINE, MS CONTIN) NO SIGNS OF ABUSE. PT HAS BEEN ON MEDS SINCE
---------------------------------------------------------------------------
2010. PT HAS BUILT UP TOLERANCE.

12/16/19 SPOKE TO MD OFFICE: ABOUT COMBINATION OF OXYCO-DONE, MS
CONTIN, XANAX, TIZANI-DINE, TEMAZEMAM. MD IS AWARE PT HAS BIPOLAR
MORBIDITY. STATES MONITORS PT FOR ABUSE. NO SIGNS OF REPIRATORY
DEPRESSION. PT HAS BEEN ON MEDS FOR OVER 5 YEARS.

Gov't Ex. 32 at 69. Similarly, a pharmacy note regarding Patient CW
provides:

12/18/19 SPOKE TO MD ABOUT COMBINATION OF HYDROMORPHONE/ALPRAZOLAM.
PT HAS NO SIGNS OF SIQUALE. NO SIGNS OF ABUSE PT HAS BEEN ON MEDS
FOR SEVERAL YRS. OK TO FILL. . . .

Id. at 13. To be sure, on their face, these highlighted pharmacy notes
are temporally outside the Government's allegations related to Patients
JM \28\ and CW,\29\ but they clearly do appear to contain analysis
regarding the combination prescribing issue and coordination with the
prescriber. These notes demonstrate that at some point the Respondent
did commence documenting conversations with the prescribers on this
issue, [which is a positive development that indicates an attempt by
Respondent's pharmacists to fulfill their corresponding responsibility
and operate within the usual course of professional practice. However,]
inasmuch as the documented resolutions are dated after the charged
misconduct, they supply no defense to the registrant in this case.
---------------------------------------------------------------------------

\28\ OSC/ISO Allegation 7.e charges that combination
prescriptions between January 9, 2019 and August 23, 2019 were
dispensed by the Respondent to Patient JM without documented
evidence that the identified combination red flag was resolved. ALJ
Ex. 1 ] 7.e.
\29\ OSC/ISO Allegation 7.g charges that combination
prescriptions between February 19, 2019 and August 28, 2019 were
dispensed by the Respondent to Patient CW without documented
evidence that the identified combination red flag was resolved. ALJ
Ex. 1 ] 7.g.

In reviewing the prescriptions that were filled by the Respondent,
Dr. Schossow also identified anomalies in regard to dosages of
controlled substance prescriptions that raised red flags. Specifically,
the witness explained that certain prescriptions did not ``make
pharmacological sense'' \30\ because of the dosing combinations of
long-acting and short-acting opioids.\31\ Gov't Exs. 6-9, 11, 12; Tr.
274-76, 281-83; Stip. 19 (Patient EA); Tr. 296-97; Stip. 21 (Patient
SD); Tr. 302-05; Stip. 23 (Patient LH); \32\ Tr. 315-16; Stip. 25
(Patient DH); \33\ Tr. 333-34; Stip. 29 (Patient JM); Tr. 339-41; Stip.
31 (Patient ST). And for at least one patient, Dr. Schossow testified
that there were instances of therapeutic duplication,\34\ which also
presented a dosage-anomaly red flag. Gov't Ex. 11; Tr. 335-38; Stip. 29
(Patient JM). The witness testified that to address a dosage-anomaly
red flag, a Florida pharmacist acting within the standard of care is
required to speak with the physician to discuss the potential dangers
and the patient's treatment plan, and then document the
conversation.\35\ Tr. 284-855, 318, 336-37. Through her testimony, the
witness explained that she saw no indication in her review of the
Government exhibits that the Respondent resolved, addressed, or
documented the dosage-anomaly red flags. Gov't Exs. 6-9, 11, 12, 15,
22-25, 27, 28, 32; Tr. 286, 371-75 (Patient EA); Tr. 298-300, 375-78
(Patient SD); Tr. 308, 378-80, 384 (Patient LH); Tr. 319, 321, 385-88,
397-98, 408-09 (Patient DH); Tr. 338-39, 413-16, 419-20 (Patient JM);
Tr. 342-43, 420-23 (Patient ST).
---------------------------------------------------------------------------

\30\ Tr. 281.
\31\ Certain controlled substances are prescribed to be taken
scheduled, in order to maintain the medication at a certain level in
the body consistently. Tr. 275-76. While other controlled substances
are prescribed to address breakthrough pain, or episodic pain, on an
as-needed basis. Tr. 276-77. Here, Dr. Schossow testified that the
Respondent was filling prescriptions where controlled substances
that are usually prescribed for breakthrough pain were prescribed on
a scheduled basis. Tr. 274-75.
\32\ The witness was unmoved by the fact that the prescription
sig was marked ``PRN,'' signifying that the medication was to be
taken on an ``as needed'' basis. Tr. 302-03.
\33\ Regarding Patient DH, Dr. Schossow's opinion is that to
resolve an identified dosing red flag within the standard of care, a
Florida pharmacy registrant would be required to demonstrate
documented ``careful justification of why [the patient] would need
so much [medicine] or the attempt of trying to lower it to a safer
dose with the physician.'' Tr. 409. [The Chief ALJ determined that
the standard outlined by Dr. Schossow was too onerous to impose on
pharmacists. However,] there is a sufficient lack of documentation
in this case that it is not necessary to reach the issue of whether
Dr. Schossow's elevated standard of documentation delivered here
meets or exceeds the required threshold. [Respondent's failure to
document any resolution of this red flag was outside the usual
course of professional practice, and a violation of its
corresponding responsibility.]
\34\ The witness defined therapeutic duplication as when two
controlled substances that act pharmacologically the same are
prescribed together. Tr. 335-36.
\35\ [Omitted for clarity].
---------------------------------------------------------------------------

Dr. Schossow also testified that instances where customer-patients
of the Respondent drove long distances to obtain and/or fill controlled
substance prescriptions were red flags that must be addressed and
resolved. Tr. 232-34; Gov't Exs. 5, 8, 10, 12, 13, 21, 24, 26, 28; Tr.
232-36 (Patient JW); Tr. 248-50 (Patient JA); Tr. 305-06 (Patient LH);
Tr. 326-28 (Patient DK); Tr. 341-42 (Patient ST); ALJ Ex. 19, Attachs.
A, C. [Dr. Schossow testified that] a patient driving long distances to
fill a controlled substance prescription presents a red flag because of
concerns ``for the safety of the patient'' as they could potentially be
driving under the influence of controlled substances. Tr. 232-34. In
order to address this long-distance red flag, a Florida pharmacist
acting within the standard of care, at least according to Dr. Schossow,
would need to question the patient on whether they were personally
driving, question the prescriber on whether they ``discussed the
dangers of the dosing of the medication in regards to operating a motor
vehicle,'' \36\ and then document the conversation/resolution.\37\ Tr.
238-39; see also id. at 306-07, 328. [Omitted as superfluous. As
discussed in more detail below, the Chief ALJ found that Dr. Schossow's
testimony regarding the distance red flag was not convincing. I agree,
and I do not give any weight to this testimony in my Decision. I have
omitted portions of the RD's discussion of this red flag for brevity.]
---------------------------------------------------------------------------

\36\ Tr. 307.
\37\ In one particular note for Patient LH, the Respondent wrote
that the patient lived in Naples, Florida. Tr. 380; Gov't Ex. 32 at
80. The witness testified that this type of notation is insufficient
and that the standard of care requires communication and
documentation regarding whether the patient is actually driving. Tr.
380.
---------------------------------------------------------------------------

Cash payments for controlled substances were also identified by Dr.
Schossow as a red flag of potential diversion. Tr. 222-23, 457; Gov't
Exs. 5-14, 21-29; Tr. 229-30; Stip. 34 (Patient JW); Tr. 242, 244;
Stip. 18 (Patient JA); Tr. 269-70; Stip. 20 (Patient EA); Tr. 296-97;
Stip. 22 (Patient SD); Tr. 305; Stip. 24 (Patient LH); Tr. 313; Stip.
26 (Patient DH); Tr. 326; Stip. 28 (Patient DK); Tr. 332-33; Stip. 30
(Patient JM); Tr. 341; Stip. 32 (Patient ST); Tr. 346; Stip. 36
(Patient CW). Dr. Schossow explained that an indication on a

[[Page 2914]]

particular prescription of ``cash'' means that the price of the
prescription was not ``charged to an insurance company, or worker's
comp.'' \38\ Tr. 222-23. The Government's expert explained that, in her
opinion, if a patient did pay in ``cash'' that she would assume the
patient had insurance but was choosing not to utilize their insurance;
a scheme she explained, in her experience, is practiced by drug
diverters.\39\ Tr. 223-28. Dr. Schossow admitted that she could not
know for certain whether a patient had insurance or not simply by
seeing the notation ``cash'' on a prescription. Tr. 226. The witness
also acknowledged that where a pharmacy is out of network, the customer
patient can submit the insurance reimbursement claim to the insurer.
Tr. 537. According to Dr. Schossow, in order to resolve a cash red
flag, within the standard of care, a Florida pharmacist is required to
ask the prescribing physician whether the patient has insurance and
document the finding.\40\ Tr. 228-29, 239, 306. A notation by the
pharmacy staff that a customer-patient did not have insurance coverage
\41\ was, in Dr. Schossow's view, insufficient to resolve the red flag
of cash payment. Tr. 367, 374, 428. Even a case where the registrant
pharmacy documented that it was not contracted with the customer-
patient's insurance carrier was insufficient to satisfy the standard
outlined by Dr. Schossow based on her expressed innate suspicion of a
customer who would not, on that occasion, seek out a different pharmacy
that accepted the prescription coverage benefit.\42\ Tr. 411. [Omitted
for brevity. The Chief ALJ found that Dr. Shossow's testimony about
this red flag was not convincing and that her standard for resolving
this red flag was too burdensome and illogical to set the minimum
standard of care in Florida. The Chief ALJ did not sustain the
Government's allegations regarding this red flag, and the Government
took Exception to this finding. As discussed below, I find that it is
unnecessary for me to reach this issue because there is substantial
other evidence on the record that demonstrates that Respondent's
registration is inconsistent with the public interest.
43 44 45 46 47 48 49 50
---------------------------------------------------------------------------

\38\ During the course of his testimony on the issue, the
Respondent's owner testified that ``cash'' can mean currency, a
credit card, or a check. Tr. 635.
\39\ The Government presented no evidence that any of the Ten
Patients were or are drug diverters. This assumption played no role
in the Government's noticed theory of its case. ALJ Ex. 1.
\40\ According to Dr. Schossow, a notation that simply states
that the patient does not have insurance is insufficient to meet the
standard of care in Florida. Tr. 374. Dr. Schossow explained that
even where a prescription contains such a notation, it is incumbent
upon the pharmacist to contact the prescriber to ensure a true lack
of insurance, Tr. 374, but conceded that ``many'' of the
prescriptions she reviewed in this case did have an indication from
the prescriber that the customer-patient was uninsured, Tr. 471.
Thus, by Dr. Schossow's view, even where the pharmacy has apparently
determined that the customer-patient is without prescription
insurance coverage and documented that conclusion on the relevant
scrip, the additional step of contacting the prescriber and
documenting the results of that conversation are required to meet
the minimum standard of care in Florida. As discussed, infra, this
makes no sense.
\41\ See, e.g., Gov't Ex. 32 at 13 (pharmacy note entered
outside the charged conduct period reflecting the Respondent's
conclusion that Patient CW paid cash because she did not have
insurance).
\42\ [Footnote omitted where text was deleted.]
\43\ [Footnote omitted where text was deleted.]
\44\ [Footnote omitted where text was deleted.]
\45\ [Footnote omitted where text was deleted.]
\46\ [Footnote omitted where text was deleted.]
\47\ [Footnote omitted where text was deleted.]
\48\ [Footnote omitted where text was deleted.]
\49\ [Footnote omitted where text was deleted.]
\50\ [Footnote omitted where text was deleted.]
---------------------------------------------------------------------------

Overall, Dr. Schossow's testimony, although not without its warts,
was generally authoritative and amply supported by the admitted
evidence of record. While her overall presentation was generally
objective, her [testimony that she] ``had a lot of patients in the
community arrested for opioid and other controlled substance fraud and
abuse,'' \51\ and her underlying assumption that customer-patients
should be assumed to be abusers \52\ (although she had no information
that this may have been the case regarding any of the Ten
Patients),\53\ were certainly concerning aspects of her testimony. [It
was also concerning that Dr. Schossow testified that] she had been a
member of the Florida Board of Pharmacy and then denied that this was
ever the case. [Omitted for brevity. I agree with the Chief ALJ that
this testimony was confusing, but there is insufficient evidence on the
record about how the Board operates and what role Dr. Schossow was
referring to that would permit me to ascribe any level of intent to Dr.
Schossow regarding this statement. Based on my review of the record, I
did not discern any intent to mislead the Tribunal, but certainly at
least her initial statement gave an incorrect impression and I consider
this statement in the same manner as the Chief ALJ did below.]
---------------------------------------------------------------------------

\51\ Tr. 137.
\52\ Tr. 368.
\53\ Tr. 444-45.
---------------------------------------------------------------------------

Dr. Schossow's testimony also contained isolated occasions where
she arguably presented as confusing,\54\ defensive, even bordering on
evasive,\55\ and the ``on-the-Board''/``not-on-the-Board'' feature was
[confusing], but she has no objective stake in the outcome of the
proceedings, and there is nothing present in the record or her
testimony that would mortally undermine her credibility and
reliability. On those points where her testimony was found reliable and
persuasive in this RD, the witness provided sufficient, detailed,
cogent support for her views. Of the two experts who testified in these
proceedings, her shortcomings notwithstanding, she is the more reliable
and persuasive, and where her testimony was at variance with the
Respondent's expert, it is Dr. Schossow's opinion which will be relied
upon.
---------------------------------------------------------------------------

\54\ See, e.g., Tr. 399-408. The witness volunteered that the
pharmacy notes she was reviewing on the stand were not the same as
the notes she reviewed prior to her testimony. Id. This anomaly was
never cogently explained by the witness. [Omitted for brevity. I
agree with the Chief ALJ that there was no ``cognizable prejudice to
the interests of justice or the Respondent's case'' from Dr.
Schossow's confusion about which notes she reviewed before the
hearing, because Dr. Schossow was clear during her testimony about
what materials she reviewed and how she formed her opinions.]
\55\ See, e.g., Tr. 243-44 (multiple attempts taken to get the
witness to state that the paperwork she examined did not have any
indication as to whether the customer-patients had insurance with
prescription drug coverage); Tr. 291-93 (significant equivocation on
whether identified red flags are resolvable, and if yes, how so);
Tr. 448-49 (significant equivocation on answering whether, during
her analysis, she had identified violations beyond failure to
document red flag resolutions); Tr. 451-52 (significant equivocation
in addressing the straightforward question of whether she had ever
read the footnotes, any of the footnotes, in a specified guidance
document issued by the CDC).
---------------------------------------------------------------------------

The Respondent's Case \*D\
---------------------------------------------------------------------------

\*D\ Throughout the Respondent's case, I have made some minor
adjustments to the wording where noted for brevity and for clarity
and to reflect more of my style. See supra n. *C.
---------------------------------------------------------------------------

The Respondent's case consisted of testimony from the Respondent's
owner and an expert witness.

Dr. Daniel E. Buffington, Pharm.D.

The Respondent presented the testimony of Dr. Daniel Buffington,
Pharm.D. Dr. Buffington's CV \56\ reflects that he earned his Doctorate
in Pharmacy in 1987, completed a pharmacy residency in 1988, and
concluded a pharmacy fellowship in 1989 that focused on pharmacy
practice and clinical pharmacology. Tr. 792-94; Resp't Ex. 12. The
witness testified that he has held a faculty position at the University
of South Florida, Colleges of Medicine and Pharmacy since the early
1990s, along with various other academic appointments and positions
where he has taught a myriad of topics regarding pharmacotherapy and
clinical pharmacology. Tr. 792, 794-95. Dr. Buffington explained that,
although he is not licensed as a consultant

[[Page 2915]]

pharmacist in Florida,\57\ his pharmacy background has included some
consultation, clinical research, and pharmacy work as both a clinical
and retail pharmacist. Tr. 796-97. His current business, Clinical
Pharmacology Services ``is a licensed pharmacy [that] also provides
direct patient consultation, manages clinical research trials, and
provides drug information support for health systems, medical
practices, but also forensics for law enforcement, government
agencies.'' \58\ Tr. 796. The witness testified that he has also served
as an expert in numerous state and federal cases and has participated
on panels relative to Florida legislative initiatives regarding
administrative code provisions. Tr. 814-15. Dr. Buffington was tendered
\59\ and, without objection from the Government, accepted \60\ as an
expert witness in Florida pharmacy practice under Florida and federal
standards, and the standard of care for pharmacists practicing in the
state of Florida.\61\ Tr. 813.
---------------------------------------------------------------------------

\56\ Resp't Ex. 12.
\57\ Tr. 793.
\58\ Dr. Buffington explained that his work includes consulting
with retail pharmacies regarding their compliance with relevant
Florida law provisions. Tr. 816.
\59\ Tr. 799-800.
\60\ During voir dire, the witness was combative and evasive
even in answering straightforward questions regarding his
qualifications. See, e.g., Tr. 805-09.
\61\ Tr. 799.
---------------------------------------------------------------------------

According to Dr. Buffington, under the applicable standard of care
for dispensing controlled substances in Florida, a pharmacist is
expected to assess every new and refill prescription presented to them
by a patient.\62\ Tr. 823. Dr. Buffington summarized his view of
applicable statutes governing the standard in Florida as follows:
---------------------------------------------------------------------------

\62\ The witness testified that in preparation for his testimony
he reviewed relevant Florida administrative code sections. Tr. 815.
In evaluating the role of an expert witness in the pharmacy context,
the Agency has held that a pharmacy expert is ``not [expected to be]
an expert in the details of state law, but [ ]he is required as a
pharmacist to understand what conduct is outside of the usual course
of professional practice in [his] state, whether that is derived
from state law, mandatory training, standards of care or
otherwise.'' Suntree Pharmacy, 85 FR 73,772.

[T]he pharmacist as the specialist in this area of pharmacology
and drug-related issues is expected, per Florida Board of Pharmacy
and regulations, to do [sic] on each new and refill prescription, to
evaluate, prior to dispensing, seven key criterions that look at
common drug-related problems. Some of those may be drug interactions
---------------------------------------------------------------------------
or duplications in therapy, dosing, drug allegories, wide variety.

Tr. 823. Regarding the issue of documentation, the witness holds the
view that there is essentially no requirement that a pharmacist
document any analysis employed for resolving any red flag issue that
arises relative to potential controlled substance diversion so long as
the medication is ultimately dispensed. According to Dr. Buffington,
the Florida state standard of care is also apparently dependent upon
whichever commercial software system any pharmacy elects to purchase
and utilize. The colloquy between the Respondent's counsel and its
expert is [notable]:

Q. Does the standard of care in Florida require that a
pharmacist document, at all, resolution of any issues by the
prospective drug utilization review?
A. No, sir. It's the pharmacist's individual prerogative and up
to their system. In some cases, their pharmacy software system may
afford some of that by process. Others, there's data entry fields.
It doesn't have to be solely contained in the pharmacy software. It
can be in secondary software. It can be hand-written. It can be
maintained in a variety of ways. They leave that up to the personal
judgment and prerogative and systems at each pharmacy.

Tr. 823-24. When asked to clarify if the standard really depends on
something as subjective and unregulated as what commercial software is
employed by individual pharmacies, the [Respondent's expert testified]:

No, sir. I'm saying it's up to the pharmacist as to which
method, or collective methods, they wish to document. There is no
format. There is no content-specific requirements with which a
pharmacist has to document the addressing of those issues.

Tr. 824. By this view, a pharmacy that elects to purchase a
substandard software system apparently can generate a lower standard of
care than a pharmacy that acquires a more vigilant system. By this same
reasoning, a pharmacy could even potentially escape regulatory scrutiny
by the acquisition of a subpar software system. Suffice it to say that
the notion that state and federal regulators intended to design a
system that creates a perverse incentive to deploy bad software to
dodge responsibility is unpersuasive. When asked again for
clarification, the Respondent's expert, after some [discussion] about
whether DURs and red flags \63\ are homonyms, stated his opinion:
---------------------------------------------------------------------------

\63\ In fact, the Respondent's expert communicated a certain
hostility to even the concept of red flags, pointing out during his
testimony that red flags is ``a colloquial term,'' Tr. 832, and in
the guidance issued by Florida and DEA ``there are no definitions of
red flags, nor is there any published requirement that guides
pharmacy practice on what, and how, to document those,'' Tr. 825. At
another point in his testimony, the witness stated he would not
document the resolution of a controlled substance red flag because
he ``can't find a consistent definition of that colloquial term.''
Tr. 936-37. This proposition [is inconsistent with] many years of
Agency adjudication addressing red flags of potential diversion
[supported by credible expert testimony] and longstanding acceptance
of the term. See, e.g., Suntree Pharmacy, 85 FR 73,769 (``When a
pharmacist's suspicions are aroused by a red flag, the pharmacist
must question the prescription and, if unable to resolve the red
flag, refuse to fill the prescription.'') (collecting cases);
Morning Star Pharmacy & Medical Supply 1, 85 FR 51,045, 51,060
(2020) (same).

[T]here is no requirement for the documentation of red flags, or
DURs, in the State of Florida. There is opportunity to document.
There is a requirement, or a duty, to address those items. The--
the--the DURs. There is no Florida-based, or DEA-based recognition
---------------------------------------------------------------------------
for documenting red flags.

Tr. 825.
The Respondent's expert later clarified that while processing a
DUR, that even when a pharmacist encounters a potential red flag issue
through its software, if ``it didn't need resolved, there's no need to
record it.'' Tr. 913. Documentation, according to Dr. Buffington, is
only required ``[i]f there's something to resolve.'' Tr. 914. When
asked if a heightened level of suspicion that supported a decision to
decline to dispense would ever merit some level of documentation, Dr.
Buffington [testified]: ``Well, first of all, I'm going to work through
whatever that question or suspicion is, and it's not going to be
documented--or, it's not going to be dispensed.'' Tr. 917 (emphasis
supplied). Following this approach, a pharmacist can subjectively
determine that there is no issue to be resolved, document nothing, and
be within the Florida standard of care. And since nothing is
documented, the only correct assumption available to regulators,
according to the Respondent's expert's view, is that everything was
correctly assessed and resolved. [Omitted.] Thus, according to Dr.
Buffington, there is no requirement under the applicable standard of
care to document any resolution regarding any indication of diversion
on the part of any patient or prescriber, no matter how egregious or
how potentially dangerous, so long as the decision was ultimately made
to dispense.
Dr. Buffington [also testified that the phrase] ``if it wasn't
documented, it wasn't done'' has no application to a pharmacy's
obligation to document the resolution of red flags because there is no
obligation to document the resolution of red flags.\64\ Tr. 825-26.
[Dr.

[[Page 2916]]

Buffington testified that pharmacists are not obligated] to document
the resolution of any controlled substance red flag because he ``can't
find a consistent definition of that colloquial term.'' Tr. 936-37; see
also id. at 940, 945. The witness suggested that requiring a level of
documentation beyond this minimalist view would require the use of
``court reporters in the pharmacy.'' Tr. 939. [Omitted for brevity.]
For, as Dr. Buffington reasoned, it is the pharmacist alone who
exercises ``professional prerogative,'' and as he, himself put it,
``someone else not understanding the core facts of [his] job doesn't
make what [he's] doing incorrect.'' Tr. 915-16
---------------------------------------------------------------------------

\64\ The witness was unpersuaded by the argument that without
adequate documentation another pharmacist encountering the same
customer-patient would be without knowledge of a red flag
determination made by a predecessor pharmacist or be able to pass
down information to a successor pharmacist. Tr. 960-61.
---------------------------------------------------------------------------

Dr. Buffington [offered an interpretation of Florida law that was
not persuasive. Tr. 826-27, 924 (discussing subsection (3)(a) of rule
64B16-27.831 of the Florida Administrative Code (Florida Pharmacy
Standards Statute or FPSS).] Subsection (3)(a) of the FPSS lists steps
to be taken by a pharmacist before declining to dispense a controlled
medication. Fla. Admin. Code Ann. r. 64B16-27.831(3)(a). The FPSS
requires a pharmacist to reach out to the patient and prescriber, or
check E-FORCSE in place of either (but not both) of those contacts
prior to declining to dispense a controlled substance. Id. r. 64B16-
27.831(3)(a), (b). [Although Dr. Buffington agrees that a pharmacist
must document his decision to decline to fill a prescription, see Tr.
827, he does not believe that a Florida pharmacist has a] duty to
evaluate the validity of the prescription or to document his/her
analysis or findings [if the pharmacist ultimately fills the
prescription.] There is no exposure so long as he/she dispenses the
drugs. [This testimony is inconsistent with the] FPSS and other
provisions of Florida law. The FPSS specifically instructs:

There are circumstances that may cause a pharmacist to question
the validity of a prescription for a controlled substance; however,
a concern with the validity of a prescription does not mean the
prescription shall not be filled. Rather, when a pharmacist is
presented with a prescription for a controlled substance, the
pharmacist shall attempt to determine the validity of the
prescription and shall attempt to resolve any concerns about the
validity of the prescription by exercising his or her independent
professional judgment.

Id. r. 64B16-27.831(2) (emphasis supplied). It is clear that in its
description of ``circumstances that may cause a pharmacist to question
the validity of a prescription for a controlled substance,'' the
Florida legislature was referring to what has been ubiquitously
referred to by DEA, the regulated community, and the industry, as a red
flag of potential diversion. Upon encountering one of these, the FPSS
directs pharmacy practitioners to consult with the prescribers,
patients, and/or E-FORCSE. The opening section of the FPSS instructs
that ``[p]harmacists shall attempt to work with the patient and the
prescriber to assist in determining the validity of the [controlled
substance] prescription.'' Id. r. 64B16-27.831. Thus, upon encountering
a ``circumstance that may cause a pharmacist to question the validity
of a prescription for a controlled substance'' \65\ (i.e., a red flag
of potential diversion), a pharmacist must reach out to either the
prescriber or the patient, and where appropriate, in place of one of
those two sources (but not both) the pharmacist may resolve a red flag
by utilizing E-FORCSE. Id. The Florida legislature has also directed
that ``[t]he pharmacist shall record any related information indicated
by a licensed health care practitioner.'' Fla. Admin. Code Ann. r.
64B16-27.800(2) (Florida Pharmacy Patient Record Statute or FPPRS). The
FPPRS also directs pharmacists to create a record of ``[p]harmacist
comments relevant to the individual's drug therapy, including any other
information peculiar to the specific patient or drug.'' Id. r. 64B16-
27.800(1)(f). Hence, contrary to Dr. Buffington's view, under Florida
law and the applicable standard of care, a pharmacist who encounters a
red flag is required, before resolving the red flag [and filling the
prescription], to contact the prescriber and/or patient and is required
to document both of those interactions.66 *E
---------------------------------------------------------------------------

\65\ Id. r. 64B16-27.831(2).
\66\ Dr. Buffington's opinion that there is no requirement for a
Florida pharmacist to consult with prescribers regarding the
existence of a clinical plan, tapering, or titration (Tr. 828) [is
also not credible].
\*E\ The Chief ALJ's interpretation that Florida law requires
pharmacists to document the resolution of red flags is supported by
a plain language reading of the various provisions of the Florida
Administrative Code and by credible expert testimony about the
importance of documentation in Florida. I agree with the Chief ALJ's
interpretation, and I agree with his conclusion that Respondent
violated Florida law by failing to document the resolution of red
flags. However, my Decision does not rely on any interpretation of
Florida law, because, in failing to document the resolution of red
flags, Respondent violated federal law in addition to state law. Dr.
Schossow offered credible expert testimony that failing to document
red flag resolution is outside the usual course of professional
practice in Florida. Although Dr. Buffington offered conflicting
testimony that documentation is not required in the usual course of
professional practice, I agree with the Chief ALJ that Dr.
Schossow's testimony regarding documentation requirements was
considerably more credible. Thus, as discussed in more detail infra,
I find that Respondent repeatedly violated federal law by filling
numerous prescriptions outside the usual course of professional
practice without adequately addressing, resolving, or documenting
red flags in violation of its corresponding responsibility. See 21
CFR 1306.04(a) and 1306.06. Respondent's violations of federal law
serve as an independent basis for my conclusion that Respondent's
registration is inconsistent with the public interest and that
revocation is the appropriate remedy in this case.
---------------------------------------------------------------------------

Contrary to Dr. Buffington's testimony that [it should be assumed
that a pharmacist has resolved any potential red flags if he decides to
fill the prescription], the Agency has made it clear that it is
unwilling to credit ``[p]ost hoc written or oral justifications'' for
actions taken as a registrant that were not documented, George Pursley,
M.D., 85 FR 80,162, 80,171 n.28 (2020); see Lesly Pompy, M.D., 84 FR
57,749, 57,760 (2019). In fact, the Agency has accepted the premise
that ``it would be reasonable to draw an adverse inference that a
pharmacist failed to resolve a red flag (or flags) from the failure to
document the resolution in any manner . . . .'' Superior Pharmacy I and
Superior Pharmacy II, 81 FR 31,310, 31,335 (2016). [Omitted for
brevity].
Dr. Buffington also testified that filling combination
prescriptions of higher dosages of short-acting medications and lower
dosages of long-acting medications does not fall below the standard of
care.\67\ Tr. 877. Likewise, the witness rejected medication
combinations referred to as ``cocktails'' as a red flag, stating that
``[e]very patient who has multiple drugs in their regiment is a
cocktail [sic].'' Tr. 955. The witness opined that simultaneously
dispensing such combinations (either opioids and benzodiazepines, or
opioids, benzodiazepines, and muscle relaxers) ``[a]bsolutely [does]
not'' fall below the applicable standard of care for Florida
pharmacists. Tr. 863-64. Dr. Buffington explained that the presentation
of such controlled substance combinations is ``not a potential issue,
the fact that it may have been flagged in a DUR, unless the patient is
experiencing complications.'' Tr. 865. This view is not only
inconsistent with the opinion of Dr. Schossow, but also the view of the
Agency, which has sustained cocktail combinations as red flags of
potential diversion requiring documented resolution. See, e.g., Suntree
Pharmacy, 85 FR 73,756 (acknowledging that DEA ``has long discussed
cocktails'' as a red

[[Page 2917]]

flag issue). Furthermore, Dr. Schossow's view of the appropriate uses
of immediate-release and extended-release medications is more
persuasive than Dr. Buffington's summary dismissal of the issue.
---------------------------------------------------------------------------

\67\ The witness reasoned that such occurrences can happen
because ``[y]ou build a therapeutic regimen that meets that
patient's specific needs and lifestyle.'' Tr. 876. ``[Y]ou don't see
that and assume that it's somehow indicative of inappropriate
patient care.'' Tr. 878.
---------------------------------------------------------------------------

The witness was likewise dismissive in considering the
applicability of the CDC Guidelines issued in 2016 regarding controlled
substance dispensing. Dr. Buffington testified that the CDC Guidelines
had no impact on the standard of care for pharmacists practicing in
Florida. Tr. 819, 907-08. According to the Respondent's expert, the CDC
Guidelines amount only to a ``recommendation to help educate
physicians,'' and a mere ``guideline, or recommendation.'' Tr. 820; see
also id. at 903 (``Typically all guidelines are recommendations, or
instructional for--they're not thresholds or limitations on
practitioners.'').
[However,] the CDC Guidelines reveal considerable specificity in
their guidance to prescribers (and by extension, to pharmacists
[filling prescriber's prescriptions]), including advisals to commence
opioids at the ``lowest effective dosage,'' preferences for immediate-
release over extended-release opioids at the commencement of opioids as
a pain treatment modality, specific guidance regarding MME levels
exceeding 50, and a preference for ``[n]onpharmacologic therapy and
nonopioid pharmacologic therapy'' for chronic pain. ALJ Ex. 39, Attach.
A at 16. Although the issue in this case is whether a particular
prescription raises a red flag of potential diversion, Dr. Buffington
altered the subject into whether the CDC Guidelines imposed a ``hard
stop, hard block, or change'' on prescribers,\68\ which [is not
relevant to the Government's allegations. Although Dr. Buffington is
correct that the CDC Guidelines do not impose a ``hard stop,'' the
Guidelines issue clear guidance to medical professionals about
prescribing high dosages of opioids:]
---------------------------------------------------------------------------

\68\ Tr. 830, 862-64.

Clinicians should use caution when prescribing opioids at any
dosage, should carefully reassess evidence of individual benefits
and risks when increasing dosage to >= 50 morphine milligram
equivalents (MME)/day, and should avoid increasing dosage to >= 90
MME/day or carefully justify a decision to titrate dosage to >= 90
---------------------------------------------------------------------------
MME/day.

ALJ Ex. 39, Attach. A at 16. At another point in his testimony, Dr.
Buffington allowed that the CDC Guidelines advise practitioners to
``use caution if [they]'re getting to 90 [MME], or be very clear that
[they] understand and have a rationale for doing that.'' Tr. 908.
Whatever be the limits of the finer points of the CDC's guidance, to
dismiss an encountered titration that exceeds 90 MME/day as an
insignificant non-issue to pharmacy practice is not a fair inference
that can or should be drawn by the plain language of the CDC
Guidelines. Neither is the subsequent policy clarification \69\ (CDC
Clarification) issued by the CDC particularly supportive of Dr.
Buffington's premise that it was issued to address ``key areas where
the [CDC] realized people, or courts, may be misrepresenting the [CDC
G]uidelines as a fixed or regulatory threshold.'' Tr. 830-31. The
principal focus of the CDC Clarification was focused on ensuring that
practitioners did not read the CDC Guidelines as supporting dangerous,
sudden, and drastic discontinuations of opioid therapy to the detriment
of patients. ALJ Ex. 39, Attach. B at 1-2. There is nothing in the
plain language of the document that runs counter to identifying a red
flag of potential diversion under the appropriate circumstances based
in some part on high opioid dosages.
---------------------------------------------------------------------------

\69\ ALJ Ex. 39, Attach. B.
---------------------------------------------------------------------------

The witness was similarly dismissive in addressing a warning \70\
issued by the U.S. Food and Drug Administration (FDA) concerning the
extreme dangers posed by combining opioids and benzodiazepines (the
Black Box Warning). ALJ Ex. 39, Attach. C. The Respondent's expert
acknowledged that a black box warning connotes a ``heightened level of
warning,'' that should inform a pharmacist's decision making, but
insisted (despite the FDA's decision to issue the warning) that it
contained no new information and was merely an advisal to prescribers
that these ``very low incident'' complications could occur. Tr. 909.
Although in its drug safety communication setting for the Black Box
Warning, the FDA refers to black box warnings as its ``strongest
warnings,'' \71\ the Respondent's expert [did not consider the warning
to be notable, and further testified that ``the combined use of the two
[medications] presents no complication or problem for healthcare
professionals specifically in chronic pain . . . .'']. Tr. 909, 959.
This view arguably stands in some tension with the plain language
contained in the Black Box Warning:
---------------------------------------------------------------------------

\70\ Also known as a boxed warning.
\71\ ALJ Ex. 39, Attach. C at 1.

Health care professionals should limit prescribing opioid pain
medicines with benzodiazepines or other CNS depressants only to
patients for whom alternative treatment options are inadequate. If
these medicines are prescribed together, limit the dosages and
duration of each drug to the minimum possible while achieving the
desired clinical effect. Warn patients and caregivers about the
risks of slowed or difficult breathing and/or sedation, and the
associated signs and symptoms. Avoid prescribing prescription opioid
cough medicines for patients taking benzodiazepines or other CNS
---------------------------------------------------------------------------
depressants, including alcohol.

ALJ Ex. 39, Attach. C at 1 (emphasis supplied). Although Dr. Buffington
reads the Black Box Warning as an authorization to continue to use (not
limit) this combination,\72\ the FDA apparently holds the view that
health care officials should limit the combined prescribing of opioids
and benzodiazepines to situations where other treatment options are
inadequate. Id. Notwithstanding this limitation (couched in directive,
not passive language), Dr. Buffington's position is apparently that the
``avoid'' aspect of the warning should be deemphasized over a
recognition that the two medications can be prescribed together. In any
event, the Government never argued that the combination is per se
prohibited, but rather that the combination raises a dispensing red
flag that requires documented resolution to meet the standard of care.
[Relocated]
---------------------------------------------------------------------------

\72\ Tr. 909.
---------------------------------------------------------------------------

In specifically addressing cash red flags, the Respondent's expert
opined that ``the method of payment is somewhat irrelevant'' and that
the standard of care ``[a]bsolutely [does] not'' require pharmacists to
investigate the rationale for a customer-patient utilizing cash
payments or insurance. Tr. 833-34; see also id. at 953. Dr. Buffington
reasoned that pharmacists ``have that capacity to understand that
patients' payment methods often ebb and flow based on [insurance]
coverage. . . . There are just so many variables that there is no
predictive validity, or use, of presuming cash payment to be a
problem.'' \73\ Tr. 833. Regarding the position of the Government's
expert that a pharmacy is required to contact a prescriber to confirm
prescription coverage details, Dr. Buffington persuasively testified
that a ``medical benefit does not always coincide with a drug-spend
benefit.'' Tr. 834. While this perspective is reasonable, declaring
cash as never a relevant consideration [is not balanced and not
credible]. The view of the Respondent's expert that cash is always
patently irrelevant to the evaluation of dispensing events is in
considerable

[[Page 2918]]

tension with the Agency's view based on credible expert testimony. See,
e.g., Suntree Pharmacy, 85 FR 73,757 n.13 (sustaining ALJ's finding
based on credible expert testimony ``that cash is a red flag in
combination with other red flags''); Pharmacy Doctors Enters., 83 FR
10,876, 10,891 (2018) (same). As can fairly be stated about other
aspects of Dr. Buffington's presentation, he was inconsistent regarding
this issue. At another point in his testimony the witness seemed to
nominally retreat from this absolutist opinion and suggested that cash
could indeed potentially be a red flag. Tr. 955. This was confusing. As
discussed elsewhere in this recommended decision, although the
rationale of the Government's case for cash as a red flag in the
present case (to wit, the pharmacy must call the doctor regarding
pharmacy insurance coverage) was unpersuasive, [I also decline to
credit Dr. Buffington's testimony that cash payments are never a red
flag.\74\ See infra for further discussion of cash payments. Omitted
for brevity].
---------------------------------------------------------------------------

\73\ Dr. Buffington reasonably opined that requiring a pharmacy
registrant to reach out to a physician's office to investigate a
patient's insurance coverage is idiosyncratic because the insurance
coverages are different. Tr. 834.
\74\ [Omitted.]
---------------------------------------------------------------------------

The Respondent's expert similarly dismissed any considerations of
long travel distances as a potential red flag. When asked whether
distance could be a potential red flag, his response was ``[a]bsolutely
not.'' Tr. 948. Beyond his eminently valid point that a pharmacist
possesses no capacity to limit the driving habits of its customer-
patients beyond recommendations,\75\ Dr. Buffington was unequivocal in
his rejection of the whole concept, declaring:
---------------------------------------------------------------------------

\75\ Tr. 873.

There's no logical rationale, or supportable--and certainly no
regulatory--oversight over that. You could live in the [Florida]
Keys and fill in the [Florida] Panhandle. You could fill at a
pharmacy you prefer, or have worked with, where you lived
previously. One that's--there are just so many variables, from your
home, your office, your doctor's office--it's purely your choice as
a consumer. There's no predictive validity that where--in fact, you
can fill out-of-state. There's not a problem for your prescription.
---------------------------------------------------------------------------
So, there is just no utility in attempting to use that as a metric.

Tr. 834-35. The witness opined that ``distance is of no predictive
value in and of itself . . . .'' Tr. 949. [He testified that he was not
obligated] to document a distance red flag, adding ``I have no
obligation to take someone else's variable and write something down.''
\76\ Tr. 951. Certainly, Dr. Buffington's broad denunciation of
distance as a red flag is directly contrary to [prior Agency decisions
based on credible expert testimony]. See, e.g., Heavenly Care Pharmacy,
85 FR 53,402, 53,417 (2020) (recognizing based on credible expert
testimony long distance as a valid red flag); Pharmacy Doctors Enters.,
83 FR 10,885 (same); Hills Pharmacy, LLC, 81 FR 49,816, 49,839 (2016);
Holiday CVS, L.L.C., 77 FR 62,316, 62,321-22 (2012) (same); E. Main St.
Pharmacy, 75 FR 66,149, 66,163-65 (2010) (same). [Omitted for brevity.]
As was not uncommon throughout the course of his presentation, Dr.
Buffington produced an answer favorable to the Respondent by changing
the question. When asked if distance could support a diversion red flag
(i.e., an issue to be resolved prior to dispensing), the witness
answered the question of whether such an issue was potentially
resolvable, which was a premise that comprised no part of the
Government's case. [Omitted for brevity.] Although the rationale
employed by the Government's expert (motor safety) was unpersuasive in
this case, the categorical dismissal of distance as a red flag under
all circumstances detracted from the reliability that should be
afforded to Dr. Buffington's testimony.
---------------------------------------------------------------------------

\76\ After repeatedly [testifying that distance was not] a
potential red flag issue, the witness testified that he ``already
said it could'' be a red flag. Tr. 952. At another point in his
testimony, the witness, in response to a direct query of whether
distance could ever be a red flag, [testified]: ``It could, but I've
already stated we already have methods for dealing with that, and I
wouldn't call it a red flag.'' Id. at 954. [Omitted for brevity.]
The inconsistencies further denigrated any ability to credit Dr.
Buffington's opinions.
---------------------------------------------------------------------------

The witness similarly transposed the issue of illogical medication
dosing combinations as a red flag. When queried on the subject, Dr.
Buffington [changed] the issue into whether such dosing variations
between extended-release and short-acting medications were
inappropriate under all circumstances, which was [not the Government's
or Dr. Schossow's theory]. Tr. 877-81. The issue in the case is whether
the Respondent pharmacy was presented with a red flag that required
follow-up, resolution, and documentation. Like most red flags, the
question presented may be (and often is) subject to resolution. Dr.
Buffington's view on the issue of illogical medication dosing is
divergent from that of Dr. Schossow, but the Government expert's
testimony on this issue was better explained, more persuasive, less
evasive, and more reliable.
[The Chief ALJ questioned the credibility of Dr. Buffington's
testimony that he performs physical examinations on pharmacy customers.
Tr. 920-21. I agree that this testimony was unusual, but I have omitted
the discussion as it does not ultimately impact my Decision.]
The Respondent's expert testified that he reviewed the relevant
documents \77\ for the Ten Patients from the Respondent pharmacy and
testified that the Respondent's controlled substance dispensing did, in
his opinion, meet the standard of care in Florida for each of the
prescriptions at issue in this matter. Tr. 845, 850-51, 859, 881. Dr.
Buffington testified that he saw no deviation from the standard of care
on the part of the Respondent in terms of over-utilization and under-
utilization,\78\ therapeutic duplication,\79\ drug-disease
interactions, drug-drug interactions,\80\ drug dosages or
treatment,\81\ drug-allergy interactions, and clinical abuse and
misuse.\82\ Tr. 845, 854, 863, 865, 868-69.\83\ Although it was never

[[Page 2919]]

entirely explained how he reached this supposition, Dr. Buffington
testified that it was his understanding that each of the prescribers
associated with the Ten Patients was a pain management specialist. Tr.
867. Whether this was the case or not, or how heavily this factor may
have weighed into his metric, this assumption appears to have
[impacted] his analysis. For each category, Dr. Buffington testified
that a showing or ``hit'' of one of these categories simply requires an
evaluation on whether the patient is experiencing complications or
side-effects, and the absence of complications or side-effects means
the ``hit'' does not rise to the level of a clinical problem. Tr. 855-
58, 860, 862-63, 865, 870. The witness testified that ``[t]hese are
categories that the Board of Pharmacy is saying you should evaluate
these issues [sic] and determine in your professional judgment if there
is something to avoid or resolve and that's the issue.'' Tr. 862. When
Dr. Buffington was asked whether the presence of an opioid and a
benzodiazepine would present a drug-drug interaction DUR, he replied in
the following confusing way:
---------------------------------------------------------------------------

\77\ Dr. Buffington testified that, in addition to the
Government Exhibits, he also reviewed Proposed Respondent Exhibits
that were not offered or admitted during the course of the hearing.
Tr. 845, 880.
\78\ The witness testified that this is ``a patient-specific
issue.'' Tr. 852. This is another instance where the witness
replaced the issue posed with one that [he preferred to discuss].
When asked about under-utilization, something that could potentially
be a red flag of abuse requiring resolution, the witness substituted
his analysis that the CDC Guidelines placed no hard cap on MME
levels, Tr. 853-57, which was not among the Government's theories.
The issue in the case was never whether a prescriber can elect to
use his/her professional judgment, but whether a particular dosage
strength can raise a potential red flag requiring inquiry,
resolution, and documentation. The witness's responses on this issue
were also (as many other answers were) seemingly dependent upon the
limits of the commercial software purchased by an individual
pharmacy, which, as discussed in detail, supra, cannot serve as a
reasonable, objective yardstick for whether a DEA pharmacy
registrant has met the applicable standard of care.
\79\ The witness defined therapeutic duplication as when two
medications of the same class, or two medications with the same
pharmacologic effect, are prescribed together. Tr. 854-55.
\80\ Dr. Buffington explained that when a pharmacist encounters
a drug-drug interaction, they are ``looking for predominantly
metabolism, secondarily effects as to whether or not that potential
for conflict is going to either create an adverse side-effect or
potentially, some medications may bind to the other'' rendering it
therapeutically useless. Tr. 861.
\81\ This specific category was explained by the witness to
typically be presented as a miss-fill on the part of the pharmacist
or a scrivener's error on the part of the prescriber. Tr. 868.
\82\ Dr. Buffington differentiated between abuse and misuse by
explaining that ``abuse could have the ill intent to produce some
effect . . . that that medication has,'' while ``[m]isuse may in
fact be that the individual is not taking the medication properly,
so poor compliance.'' Tr. 870.
\83\ Regarding Patient JM, Dr. Buffington testified that the
customer-patient receiving Restoril and Xanax at the same time
``would not present a problem that needed resolved, unless, in fact,
in the dialogue and counseling with that patient, you've identified
a clinical concern where the patient is expressing they're not
getting therapeutic benefit or possibly too much therapeutic
benefit.'' Tr. 856.

No. Because those two are used routinely together. Now, could
you--in other words there's no certainty that that software system
is going to flag the two of those--that's something that the
practitioner will understand. It may, based on the vendor who made
the software or the pharmacy who added an additional manual edit to
be part of that process, but none of these are hard stops with any
---------------------------------------------------------------------------
regulatory oversight.

Tr. 862. In specifically addressing duplicate therapy in regards to
Patient JM, Dr. Buffington provided, ``The mere presence of the two
together do[es] not create the red flag. It's as though someone is
creating or propagating the fact that if the two appear, materialize in
the same regiment that it is wrong. It is not wrong unless problems
ensue . . . .'' Tr. 968-69. The witness consistently alluded to a high
level of deference and prerogative left, at least in his view,
exclusively (and apparently un-reviewably) to the dispensing
pharmacist, when he explained that for any of the categories,
documentation is required only if an issue is identified (by the
pharmacist). Tr. 866.
As discussed, supra, a recurrent theme in the testimony of this
witness was to eschew the issue at hand and substitute an issue he
would prefer to address. At one point during his testimony, the witness
was asked whether ``patient questionnaires that were presented by [the
Respondent] to new patrons . . . [is] something that [pharmacies are]
required to maintain by any statute or regulation.'' Tr. 851-52. Dr.
Buffington's answer was ``No, just routine practice.'' Tr. 852.
Unanswered by the expert here is whether patient questionnaires are
required to meet the applicable standard of care as subsumed by both
federal and state statutes and regulations, and/or whether the
``routine practice'' employed by Florida pharmacies in his estimation
comprises any portion of the applicable standard of care. Similarly,
when asked whether there is a requirement for Florida pharmacists to
document resolution of over-utilization, under-utilization, therapeutic
duplication, and drug-disease contraindications, the witness's answer
again injected an intentional level of equivocation:

Only if you in the course of, normal course of your practice
identified there was an issue, a clinical presentation, a concern,
something that might be hindering medication compliance and the
likes, then, upon recognizing those, if it's a concern during your
evaluation, then you could take the steps to avoid and resolve the
problem.

Tr. 866. The framework of the witness's answer here, like many of his
answers, was unhelpful, and seemingly deliberately so. A red flag
indicating a potential diversion issue is ``a concern'' or ``an
issue,'' or even ``something that might be hindering medication
compliance and the likes.'' \84\ Thus, the interpretation that nothing
is required of the pharmacist upon encountering a red flag creates an
unhelpful level of a sort of plausible deniability. Another example of
this is apparent in the witness's explanation of subsection (1)(g) of
rule 64B16-27.810 of the Florida Administrative Code (Florida DUR
Statute), which requires the identification of ``[c]linical abuse/
misuse.'' Although the statute supplies no limitation regarding the
nature of clinical abuse/misuse, the Respondent's expert explained this
aspect of the operation of the Florida DUR Statute in this circuitous
manner:

\84\ Tr. 866.

That means if you've identified as a practitioner that the
patient is abusing or misusing the medication, and we state it that
way for very specific reasons, abuse could have the ill intent to
produce some effect, some main effect or side-effect, that the
medication has. Misuse may in fact be that the individual is not
---------------------------------------------------------------------------
taking the medication properly, so poor compliance.

Tr. 869-70. When juxtaposed, Dr. Buffington's dismissal of almost all
red flags of potential diversion as nonissues with the pragmatic
operation of his interpretation of the Florida DUR Statute is quite
interesting. There are virtually no red flags that can or should
motivate the pharmacist to resolve prior to dispensing a controlled
substance (as opposed to declining to do so), so to the extent the
pharmacist intends to fill the prescription, there is no need to
contact the prescriber or discuss any issues with the patient.\85\
Thus, there is no real way (perhaps short of some extreme demonstration
of intoxication or other drug-seeking behavior exhibited by a customer-
patient which is observed and conveyed to the pharmacist by pharmacy
staff, or other equally unlikely scenario) for the pharmacist to
identify abuse or misuse. The pharmacist's obligation under the Florida
DUR Statute is [minimized to virtually no obligation, under Dr.
Buffington's view].\86\ Under an interpretation where there is no
obligation to do anything beyond inexorably dispensing medications
(with as substandard a software system as can be found), the pharmacy
registrant [does not have a meaningful role of oversight]. [Omitted for
brevity.]
---------------------------------------------------------------------------

\85\ Dr. Buffington restricts a pharmacist's obligation to
``doing a valid check on the legitimacy of the prescription in terms
of having done your homework and understanding the prescriber,
having done your homework and understanding the patient . . . .''
Tr. 867. There was no clarification from the witness as to what
objective steps could or must be invested in ``understanding'' the
patient and prescriber, or what any of that means. At another point
in his testimony, the Respondent's expert explained his view that
validating a prescription would include an evaluation of the scrip,
the completeness of the scrip, the prescriber's authority, and
whatever evaluation steps are included in the pharmacy software. Tr.
909-10. When pressed upon the issue of whether risk plays a role in
the assessment, Dr. Buffington stated that ``every medication has
risk'' and based his answer, not on whether a red flag is triggered
by the level of risk, but whether a risk, standing alone,
constitutes ``a preclusion,'' which he naturally answered in the
negative. Tr. 911-12. The issue with red flags in this case, as
alleged by the Government, never included a hard preclusion
component, but only whether the evidence demonstrated unresolved red
flags of potential diversion which remained unresolved and
undocumented prior to dispensing.
\86\ In responding to a hypothetical, the Respondent's expert
[testified] that even if newly-issued CDC guidelines indicated that
a medication at a particular dosage level could result in physical
harm to the patient, he would continue to dispense based on nothing
more than the prescriber's unexplained insistence. Tr. 905.
---------------------------------------------------------------------------

In opining that the Respondent met its corresponding
responsibility, the witness stated that ``corresponding responsibility
is specific to that if either party, the prescriber, or the dispenser,
knowingly fills a medication that is illegitimate; I saw no evidence
that there was any illegitimate medications, prescriptions that were
filled in this case.'' Tr. 881. Dr. Buffington made it clear that the
decisions made by the pharmacist, in his view, are not amenable to
review by others. To the witness, a controlled substance

[[Page 2920]]

prescription becomes invalid, potentially unfillable, only when there
is a ``[k]nowing that the patient was using the product
inappropriately--they were abusing. Knowing that the patient was going
to be handed the prescription but was misusing.'' Tr. 914.
Interestingly, Dr. Buffington explained that the concept of knowing is
based purely on ``professional prerogative,'' \87\ that the dispensing
pharmacist is ``the one that has to discern if [they] know, or have
reason to know--not a third party who's evaluating that.'' Tr. 917. The
witness's standard strikes as an unreviewable judgment call on the part
of the dispensing pharmacist. [Dr. Buffington appears to believe] that
every pharmacy registrant is possessed of essentially un-regulatable,
unreviewable authority. [This position is inconsistent with the]
highly-regulated field such as pharmacy and the dispensing of
controlled substances.
---------------------------------------------------------------------------

\87\ Tr. 915.
---------------------------------------------------------------------------

When questioned on an objective component of the concept of
knowing, Dr. Buffington explained that, in his opinion, ``[t]he Florida
Board of Pharmacy defines that.'' Tr. 921. Dr. Buffington suggested at
one point in his testimony that the state standard of care bears no
correlation to the regulatory administration of a DEA registration. Tr.
922-23. When pressed on whether his opinion would change to any extent
if the Agency had interpreted knowing in a certain way, Dr. Buffington
discounted DEA's authority in this way:

Well they don't have--the DEA doesn't have the training or the
expertise, and has never provided a valid instrument that is
predictively--with predictive valid--validity--that demonstrates the
method they would use to discern that.

Tr. 928.
[The Chief ALJ found that Dr. Buffington was hostile to DEA as a
regulator, based on Dr. Buffington's testimony that he does not believe
that DEA regulations or Agency decisions inform pharmacy practice in
Florida, or that Agency decisions ``even translate[] to something that
is enforceable.'' Tr. 930, 947, 983. I agree with the Chief ALJ that
this testimony is legally incorrect to the extent that it implies that
DEA has no relevance to a pharmacist's corresponding responsibility in
dispensing controlled substances. Because of DEA's role in ensuring
that controlled substances are distributed only through lawful
channels, and its authority to revoke or suspend DEA registrations, it
is incumbent on pharmacies to be familiar with DEA decisions and create
pharmacy policies that ensure that pharmacists are fulfilling their
corresponding responsibility. See Suntree Pharmacy, 85 FR 73,753,
73,770 (2020); see also S&S Pharmacy, Inc., 46 FR 13,051, 13,052
(1981). DEA publishes final orders in administrative proceedings
involving doctors, pharmacies, and other DEA registrants, which provide
final adjudications on the public record of DEA's expectations for
current and prospective members of the registrant community regarding
their obligations under the CSA, in particular how the provisions of
the CSA are adjudicated in enforcement actions.] [Omitted for brevity.]
Overall, even setting aside the multiple inconsistencies,
evasiveness, and views he espoused that are directly contrary to the
Agency's prior decisions, Dr. Buffington's expressed antagonism for the
regulatory authority vested in DEA and the Administrator undermines the
weight that can be attached to his presentation. While there is no
question that the witness's credentials were impressive, Dr. Buffington
[presented as an advocate for Respondent rather than as an impartial
expert]. That is not to say that Dr. Buffington is entirely unreliable.
This witness is an experienced and well-credentialed professional.
There were certainly aspects of his biographical information, the
progress of his career, and even some testimony regarding dispensing in
general that presented as sensible and consistent with the record.
However, where Dr. Buffington's views conflict with the views expressed
by Dr. Schossow, at least where her views have been deemed reliable and
well-supported in this RD, it is her expert opinion that must be
afforded greater weight.

Dr. Aaron Howard, Pharm.D.

The Respondent (while still represented by qualified counsel)
presented the testimony of Dr. Aaron Howard, the owner and pharmacist-
in-charge (PIC) of the Respondent pharmacy. The witness (Dr. Howard,
the Respondent's owner, or the owner) testified that he received his
Doctorate in Pharmacy in 2003 and has spent the vast majority of his
career as a licensed pharmacist working as a retail pharmacist. Tr.
583-84. His experience consists of work in chain and independent
pharmacies, work in a hospital pharmacy,\88\ as well as opening and
establishing various pharmacies (including the Respondent pharmacy in
2010). Tr. 584-89.
---------------------------------------------------------------------------

\88\ The Respondent testified that in 2003 he worked as a
clinical pharmacist at Jackson Memorial Hospital. Tr. 589.
---------------------------------------------------------------------------

The Respondent, doing business under the name ``At Cost RX,'' is an
independent pharmacy and the witness explained that its business model
was designed ``to target patients who need prescription drugs who do
not have insurance or are under insured.'' Tr. 589-90. Dr. Howard
testified that the Respondent pharmacy operates a membership program
wherein the majority of its customer-patients pay for their
prescriptions in cash. Tr. 590-91. ``[T]hat's [its] whole niche.'' Tr.
591. According to Dr. Howard, upon paying a membership fee, a customer-
patient can purchase medications at the Respondent pharmacy for prices
below those found in chain pharmacies in the local area. Tr. 591. The
discounted price is extended as a benefit of the membership. Id. The
witness explained that the Respondent's discounted price system and
business model is designed to target ``patients who are underserved or
do[ ] not have insurance.'' Tr. 1212. The ``At Cost'' name of the
pharmacy is designed to convey the Respondent's primary business
objective of offering medications to its customer-patients at a
discounted price. Tr. 1213. [However, there is] no evidence of record
that any of the Ten Patients held memberships to this purported
discount program, which renders the force of this evidence as only
marginally relevant. While the Respondent employs multiple pharmacists,
Dr. Howard testified that he is the owner and the only pharmacist in
the organization that dispenses controlled substances. Tr. 605.
Dr. Howard outlined the Respondent's pre-dispensing processes, or
drug utilization review (DUR). He testified that he is the person who
conducts the DUR at the Respondent pharmacy,\89\ that the procedure is
conducted as the prescription is being processed,\90\ and that these
processes have been the subject of some level of evolution over time.
Tr. 600. The owner testified that he places his initials on the
prescription under review to signify that the DUR steps have been
undertaken and completed. Tr. 735-37. Dr. Howard's depiction of the
Respondent's DUR strikes as being strongly dependent upon queries
generated by the commercial electronic software (RX30) utilized by the
pharmacy.\91\ Tr. 607-10, 711-13, 736, 758, 1201-02, 1213-14. The owner
indicated that the RX30

[[Page 2921]]

assists him in identifying red flags of over-utilization/under-
utilization, therapeutic duplication, and drug-disease
contraindication. Tr. 712. When a patient presents at the Respondent
pharmacy with a controlled substance prescription, Dr. Howard testified
that there are a number of steps that he progresses through to verify
the validity of the prescription. Tr. 596. However, he testified that
there was no set order for the functions to be completed and
memorialized on the prescription.\92\ Tr. 770. As initially explained
by the witness, where he is unfamiliar with the prescriber, the
verification process begins with consulting websites maintained by DEA
and the state of Florida to ensure that the prescriber's state license
and DEA registration are active and without discipline or
restrictions.\93\ Tr. 596-97, 600-01. The owner testified that he also
reviews the specialty of the prescriber. Tr. 601.
---------------------------------------------------------------------------

\89\ Tr. 710-11.
\90\ Tr. 711.
\91\ Dr. Howard testified that the Respondent pharmacy has been
using RX30 software since 2010. Tr. 1169.
\92\ When pressed on the steps taken in the Respondent's DUR
protocol, the Respondent's owner/PIC was either unable or unwilling
to explain whether the steps occur in a defined order. Tr. 1192-95.
There was arguably an evasive quality to the testimonial exchange
with questions answered with questions and where a clear message was
conveyed that the witness was unwilling to be locked into a set
order of steps in the DUR process. Id.
\93\ After the initial check, the prescriber verification
process is performed annually. Tr. 605-06. No documentation was
offered to support this step. [Omitted for clarity].
---------------------------------------------------------------------------

The owner testified that he then converses with the customer-
patient regarding ``basic elements, how long they've been taking the
medication, why they're taking the medication, things of that nature.''
Tr. 597; see id. at 737. To ensure that the presented patient is the
patient for whom the prescription was written, the Respondent requires
the presenting patient to show a government-issued photo identification
card.\94\ Tr. 598-99, 737. The next step involves accessing E-FORCSE to
ascertain when the patient last had a controlled substance prescription
filled. Tr. 597, 736. The owner described the state E-FORCSE database
as ``a great tool'' that he uses to look for evidence of patient
doctor-shopping, duplicate or inappropriate therapy, as well as early
refills, and that he notates the execution of a check of this system on
the prescription itself.\95\ Tr. 611-13. If a customer-patient is
accepted by the Respondent, Dr. Howard explained that he/she will fill
out a questionnaire,\96\ which may prompt additional questions/
conversation with the patient. Tr. 598. Strangely, although the witness
claims the questionnaires have been used by the pharmacy since 2015 and
are maintained indefinitely,\97\ these documents were not produced by
the Respondent when it was served with two successive DEA investigative
subpoenas requiring, inter alia, production of:
---------------------------------------------------------------------------

\94\ While Dr. Howard testified that he asks for a government
photo ID to verify the identity of the customer-patient, he also
volunteered that he does not know if this step is a state mandate.
Tr. 599.
\95\ The majority of these notations consisted of a check mark
and ``PDMP'' or ``PMP.''
\96\ Dr. Howard testified that the Respondent began utilizing
questionnaires in 2015 and that copies of the questionnaires are
maintained indefinitely at the pharmacy. Tr. 599-602, 1125.
\97\ Tr. 599-602, 1125.

[C]omplete medication or patient medication records/profiles
that the pharmacy maintains which documents any and all
prescriptions filled by the pharmacy; any and all additional records
documenting the steps taken to avoid or resolve any issues with the
prescriptions presented by [the named customer-patients] pursuant to
the requirements of the Florida Statutes and Florida Administrative
Code 64B16-27.800 . . . and, any other documentation kept by the
pharmacy in connection with the filling of prescriptions or
providing medical treatment for these individuals, including but not
limited to dispensing reports, billing records, [E-FORSCE] reports
---------------------------------------------------------------------------
and medical records.

Gov't Ex. 2 at 1; see Gov't Ex. 18 at 1. That the Respondent made a
choice to hold these documents back from investigators, even in the
face of a subpoena, does not further the strength of its position, or
its efforts to rely on these items during the course of the hearing. In
fact, the adverse inference sought by the Government in this case \98\
is appropriately taken here. The Agency has found it appropriate to
take an adverse inference where a party has made a ``decision not to
provide evidence within its control . . . .'' Morning Star Pharmacy, 85
FR 51,063 n.38; see Pharmacy Doctors Enters., 83 FR 10,899.
Accordingly, the decision to withhold the documents that were the
subject of the subpoena gives rise to the inference (taken here) that
the information therein would not be supportive of the Respondent's
case; that is, that there was either no helpful documentation in those
papers, or that the documentation reflected therein would be
detrimental to the Respondent's case.
---------------------------------------------------------------------------

\98\ ALJ Ex. 55 at 45.
---------------------------------------------------------------------------

Although the owner testified that the Respondent's DUR protocol has
no set order,\99\ he also testified at one point that the last step in
the verification process involves reaching out to the prescribing
physician's office.\100\ Tr. 598. Although, according to the owner, he
routinely reaches out to prescribers, he conceded that he does not
document the substance of those conversations. Tr. 602-03. He explained
that because he is the only pharmacist at the Respondent pharmacy that
dispenses controlled pain medication, he keeps this information in his
head. Tr. 603-05. According to Dr. Howard, he discusses a wide range of
information with the prescribing doctors, such as treatment plans,
modifications, and red flags. Tr. 616. When pressed on the issue of
whether anomalous information received from the prescriber ever raises
a concern that triggers a decision to decline dispensing, the owner
would only go so far as to say ``I have done that in the past,'' but he
readily admitted that he keeps no list or other documentation
concerning the occasions where that has occurred. Tr. 604-05. It is the
owner's estimation that he has only run into a single prescriber that
he would place in the category of suspicious to the point where the
Respondent pharmacy would decline to dispense on his controlled
substance prescriptions. Tr. 605. In further explaining the decision
not to document prescriber concerns or keep a list of suspicious
prescribers, the witness offered the following:
---------------------------------------------------------------------------

\99\ Tr. 770.
\100\ At another point in his testimony, he testified that the
last step was filling the prescription. Tr. 1193.

No, I don't keep a list, you know, because that's an independent
judgment call. You know, you can't--well, I've seen people who've
gotten in trouble for saying I'm not going to fill this particular
physician because of X, Y, Z. I don't think that's legal. I think
you can subject yourself to legal ramifications, but my protocol,
since I'm the only pharmacist there, if it's something that I don't
agree with that has happened with that particular physician, I don't
fill it. I don't keep a printout stating that I don't fill these
---------------------------------------------------------------------------
particular physicians.

Tr. 604-05. Thus, the decision not to document or maintain a list of
suspicious prescribers is based on the owner's concern that by
documenting his analysis or the result of the pharmacy's regulatory
obligation to exercise its corresponding responsibility (which he is
legally obligated to do), he and/or his pharmacy would be vulnerable to
some theoretical legal exposure.\101\ This theoretical legal concern
seems to be in some tension with the rational and non-theoretical
concern that by failing to document the exercise of the pharmacy's

[[Page 2922]]

corresponding responsibility, the pharmacy would be subject to a
sanction against its DEA registration.
---------------------------------------------------------------------------

\101\ No legal theory was ever offered by the Respondent to
support this hypothetical concern of legal exposure for doing its
job.
---------------------------------------------------------------------------

According to the owner, the RX30 is useful in checking for
medication conflicts, allergies, and some treatment concerns, which,
unlike the corresponding responsibility outcomes and analyses, Dr.
Howard claims he does document. Tr. 613-15. Further, the RX30 system
automatically prints out some drug-specific information and cautionary
information for each patient. Tr. 618-19. The owner testified that, in
addition to the RX30-generated patient information, he interacts with
and counsels ``each patient'' regularly, inquiring about side effects,
efficacy, and observing any overt signs of mobility limitations. Tr.
619-20.
Regarding distance as a potential red flag, Dr. Howard testified
that the extent of the Respondent's distance-curiosity extends only to
the zip code supplied by the patient-customer. Tr. 635. The witness
provided the following elaboration on the subject:

I look at the patient's Florida ID and I look at the zip code.
If it's within the same three-digit zip code of our location, then
there's nothing for me to ask pertaining to the patient. If it
doesn't, then what I do is I inquire what's the reason why they're
coming to our pharmacy . . . [, to ascertain t]he specific reason
why they would travel to our pharmacy[.] Is it because of the
prices? Is it because, you know - that's pretty much it.

Tr. 635-36; see also id. at 738, 1173-74. Thus, it appears that the
Respondent looks at the customer-patient's zip code,\102\ and if the
distance is outside the three digits of the pharmacy's location, the
patient is asked whether it is the Respondent's (presumably discounted)
prices that has attracted the person to make the trip.\103\
---------------------------------------------------------------------------

\102\ Since no evidence was received regarding the significance
of postal zip code digits, this process could not be the subject of
any intelligent analysis on the issue of whether it rationally
furthered the objective of identifying distance red flags concerning
the customer-patients.
\103\ [Omitted based on the Chief ALJ's finding that the
Government did not adequately prove that long distances traveled
were a red flag in this case.]
---------------------------------------------------------------------------

Dr. Howard presented some more specific testimony concerning the
Ten Patients that are the subject of the OSC/ISO. He testified that he
had some familiarity with Patient JA's medical conditions. Tr. 714-15.
According to Dr. Howard he spoke to this patient every month, and
discussed his ailments and medications with Patient JA's multiple
treating physicians.\104\ Tr. 714-716, 739, 750-51. The witness
testified that through his review of a prescriber's note on the
prescriptions,\105\ he was aware that Patient JA had no insurance. Tr.
752-54. His representation of some patient familiarity notwithstanding,
beyond being led through some of the Government-supplied prescriptions,
the only litigation vehicle apparently available to discuss Patient
JA's treatment was to have his (then) counsel repeatedly refresh his
recollection by allowing him to peruse excluded/inadmissible pharmacy
patient records as he was testifying by VTC.\106\ Tr. 741-51, 755-57.
Obviously, the weight that can be attached to testimony borne of the
essentially ministerial act of a witness reading comments from
documents that were insufficiently reliable to introduce into evidence
is gravely diminished, but this evidentiary contrivance was endured at
the hearing to afford the Respondent every possible measure of due
process.\107\
---------------------------------------------------------------------------

\104\ The witness's memory was refreshed with an excluded
exhibit (Resp't Ex. 1(ID) at 49) to relate the existence of a
Patient JA questionnaire (and essentially read from it). Tr. 733-34.
\105\ See, e.g., Gov't Ex. 5 at 11.
\106\ As discussed, infra, the Respondent initially offered into
the record a set of Proposed Respondent Exhibits (Resp't Ex. 1(ID)
at 41-90) that purportedly related to Patient JA. Although untimely,
the Government's timeliness objections were overruled to afford the
Respondent the maximum level of due process. Tr. 642-60. However,
other fundamental issues regarding inadequate foundation and
reliability precluded the admission of the tendered evidence as
being sufficiently reliable to be considered in this adjudication.
See 5 U.S.C. 556(d). It is telling that after the anomalies
regarding Respondent Exhibit 1(ID) were discovered, the Respondent's
(then) counsel did not seek to offer the balance of the Proposed
Respondent Exhibits that related to the nine other charged customer-
patients. It is reasonable to assume that the unoffered documents
suffered from the same reliability issues, but as they were not
offered, such an assumption or further discussion is not required.
Instead, the balance of those unoffered and outside-of-record (OOR)
documents were used by the Respondent to refresh the recollection of
the owner for each of the Ten Patients.
\107\ No attempt was made by the Respondent to seek to introduce
any of the refreshing documents as past recollection recorded. See
Fed. R. Evid. 803(5). Ironically, on the last day of his testimony,
when asked about whether he even remembered his testimony being
refreshed on the previous day, the owner snapped ``That was
yesterday. I can't remember. What--I guess what's your question?''
and ``I don't recall yesterday, but whatever --.'' Tr. 1189. Suffice
it to say that announcing under oath that he has no recollection of
events occurring on the previous day is singularly unhelpful to the
credibility of a witness asking the tribunal and the Agency to
credit his recollection of events that occurred months and years
prior.
---------------------------------------------------------------------------

Evidence was presented in like manner regarding his understanding
of Patient EA. The Respondent's owner recalled that the customer-
patient was overweight, complained of leg pain, worked as a shutter
installer, and that he spoke with him monthly. Tr. 762-63. He also
recalled having conversations with Patient EA's prescribing doctor. Tr.
772. The remainder of the details were furnished by refreshing the
owner's recollection through Government-furnished prescriptions, OOR
documents, and reviewing marks he testified that he had placed on
dispensed prescriptions. Tr. 764-73, 777-90, 999-1006.
The testimony followed the same pattern regarding Patient SD. The
witness testified that he conversed with this customer-patient monthly
and communicated with the prescriber. Tr. 1007, 1014. The owner again
tracked along with the markings on the prescriptions as a guide to the
DUR (which he presented as always being completed), he examined the
prescriptions supplied by the Government in its exhibits, and refreshed
his recollection with OOR documents as before.\108\ Tr. 1007-30.
---------------------------------------------------------------------------

\108\ There was even a point during Dr. Howard's testimony where
his counsel forgot to employ the contrivance of having his
recollection refreshed and the process devolved to the witness
simply reading content verbatim from the OOR documents pertaining to
Patient SD into the record. Tr. 1025-27. Suffice it to say that this
did not enhance the credibility and force of his testimony, or the
weight to be accorded to it.
---------------------------------------------------------------------------

The same general mechanics were again applied by the Respondent in
addressing charged prescriptions regarding Patient LH. The witness
testified that he also had monthly interactions with Patient LH, that
he was familiar with his prescribing physician, that the handwritten
markings on the Government-furnished prescriptions signified that he
employed every step of the Respondent's DUR protocol, that he
considered any and all red flags, and that he had them conclusively
resolved by discussions with the customer-patient prior to dispensing.
Tr. 1030-47. Regarding a drug-drug interaction flag that was presented
in the OOR documents, and upon realizing that even the documents
contained no articulated resolution, the witness [testified]: ``Yeah. I
assessed it in my mind. There's no inter--there's no issue with him
taking that medication.'' Tr. 1043. On the same red flag, when asked
about how the issue was actually resolved, the witness merely added:
``The [RX30] system flags it. I flagged it in my mind that that's not
a[n] issue.'' Tr. 1044. Upon a third effort to attempt to help the
witness explain how the red flag might have been analyzed and resolved,
the owner became visibly impatient and said ``Well I don't know how
else to explain it.'' Id. [Omitted for brevity.] The rationale here is
apparently that because he dispensed the medicine he must have resolved
whatever red flags may have been connected with the transaction. Either
the witness was

[[Page 2923]]

being truthful and his analysis was really no cognizable analysis, or
the red flag was never really considered before the medication was
dispensed. Neither scenario furthers the Respondent's interests in
avoiding a registration sanction in this case. Even the subsequent
leading, rehabilitation questions from the Respondent's counsel about
whether he believes he ``[w]ould [ ] have filled the prescription if
[the red flag] had not been resolved'' \109\ [did not rehabilitate the
witness on this issue].
---------------------------------------------------------------------------

\109\ Tr. 1045.
---------------------------------------------------------------------------

The testimony of the Respondent's owner regarding Patient DH
followed the same general configuration. There was some testimony
regarding the customer-patient's diagnoses.\110\ Tr. 1058. The
witness's memory also was refreshed \111\ using a patient questionnaire
that was also not offered or admitted into the record. Tr. 1059-64. At
one point during the witness's testimony about Patient DH he testified
that he spoke to the prescriber to resolve a drug-drug red flag, then
when pressed, retreated to the language of the refreshing document, and
corrected his testimony to reflect that he only consulted with the
patient on the issue. Tr. 1068-71. It is reasonable to infer that a
recurring theme for this witness was to somehow ascertain the most
advantageous answer, which often came from the refreshing documents.
---------------------------------------------------------------------------

\110\ [Omitted for brevity.]
\111\ Even though this process had repeated itself numerous
times, when asked by his counsel whether he had ``an independent
recollection of the flags that were raised and resolved with respect
to the first set of prescriptions that [he had been asked] about
with [Patient] DH,'' he answered that he did. Tr. 1066. Thus, it
would have appeared that the witness's memory was not in need of
refreshing. When asked about it, the witness then immediately said
``No, I don't recall.'' Id. Like many other features of this
witness's testimony, this feature did not enhance the credibility of
his presentation. This additional anomaly notwithstanding, the
Respondent's counsel was permitted to continue to refresh the
owner's recollection with excluded documentation to afford the
Respondent the maximum margin of due process.
---------------------------------------------------------------------------

The testimony was very much the same with respect to Patient JM.
The owner averred that he saw the patient monthly, that he spoke with
her prescribers, and while on the stand he had his recollection
refreshed with OOR documents. Tr. 1102-35. The recognition of marks on
prescriptions regarding Patient JM again allowed him to assure the
tribunal that all appropriate steps were taken. Tr. 1118-19, 1129-35.
One aspect that was unique to the witness's refreshed recollection
regarding this patient is that, the testimony of the Government's
expert notwithstanding, the owner insisted that prescribing two
different benzodiazepines simultaneously to one patient is ``not a
problem.'' Tr. 1111. The owner dismissed the entire issue this way:
``So I did hear previous testimony stating that that's an issue, it's
absolutely incorrect.'' Tr. 1111-12. Simultaneous prescribing of
multiple opioids received the same treatment from the owner. When asked
if this practice raised a red flag, his answer was ``[a]bsolutely
not.'' Tr. 1112. He saw no red flags that required resolution. Tr.
1116.
The owner's testimony regarding Patient JW was more of the same. He
said he spoke to the patient once a month, spoke with his prescriber,
and read off of a litany of OOR documents purportedly to tender a more
refreshed recollection. Tr. 1139-50. Interestingly, the owner opined
that the administration of methadone for pain is common. Tr. 1146.
Whether through disinterest, witness fatigue, self-interest, or some
other cause, when asked by counsel whether his testimony regarding the
significance of the prescription annotations extended to all the
prescriptions received in the record, the witness first said ``No it
wouldn't,'' but upon being pointedly re-asked the same question by the
Respondent's counsel, the witness then agreed that it would. Tr. 1148-
49. This seeming recurrence of the witness's willingness to say
whatever answer he believed would be most helpful to his cause was not
a credibility-enhancing feature of his presentation. Sworn testimony
where a witness definitively responds yes and then upon being abruptly
asked the same question a second time responds no hardly presents a
model for reliable evidence.
The same pattern persisted regarding the witness's testimony
concerning Patient CW. More refreshing that followed seemingly rote
assurances that the customer-patient was seen monthly, and a blanket
statement that no concerns regarding the dispensing events were
encountered.\112\ Tr. 1151-64. Tellingly, when asked by the
Respondent's counsel whether the owner specifically recalled any
physical observations regarding Patient CW, the witness replied:
---------------------------------------------------------------------------

\112\ The witness testified that he did see a PMP anomaly
regarding a new prescriber, raising a conflict that he purportedly
resolved through conversations with the customer-patient and the
prescriber, some details of which were memorialized in a July 31,
2019 handwritten note on the applicable prescription. Tr. 1163-64;
Gov't Ex. 29 at 5.

Well, yeah. I mean, I've been knowing her for probably since
2012, so I can't remember like right off the top of my head, right
now, as far as--I can't remember right of the top of my head. I'm
---------------------------------------------------------------------------
not sure.

Tr. 1152. Thus, when first asked, the witness responded that he did
recall some physical observations about the customer-patient, but then,
apparently realizing that he might be called upon to relate some of
those observations, reversed course and said he was not sure and could
not remember them ``off the top of [his] head.'' Id. Prescribing
multiple opioids simultaneously also was, in the opinion of the owner,
undeserving of any particular heightened scrutiny. Tr. 1156. The
witness's view of disregarding the Government expert's view regarding
this red flag was merely that the patient-customer had ``been on pain
management therapy for a very, very long time that I can remember . . .
[for] a lot of different ailments . . . .'' Id. Thus, the owner's
account presents a binary choice: Either there is no red flag inherent
in prescribing multiple opioids and the Government's expert is wrong,
or the mere fact that the patient has been receiving medications in the
face of a long-term unresolved red flag of potential diversion is
completely dissipated by the fact that the dispensing (from the
Respondent pharmacy) has been conducted in this manner for a long time.
Neither scenario is particularly persuasive. The testimony of the
Government's expert regarding the validity of this multiple-opioid red
flag is persuasive, and the fact that a red flag was ignored for a
sustained period does not deprive the red flag of its soundness.
The presentation pattern was substantially repeated regarding
Patient DK. Tr. 1078-1101. The witness did convey some seemingly
contemporaneous memory about Patient DK, remembering some particulars
about her treatment and about the fact that (according to the owner) a
caretaker regularly dropped her off to retrieve her medications. Tr.
1086-88. But the Respondent resorted to the same recollection
refreshing regarding the significant particulars of the dispensing
events. One feature of the owner's testimony regarding Patient DK was
particularly telling. When directed to one of the Government-furnished
prescriptions issued to this patient, the Respondent's counsel invited
his attention to what appeared to be a seemingly commendable notation
on the prescription that purportedly synopsized a conversation between
the owner and Patient DK concerning her diagnoses, weight loss, and
pain

[[Page 2924]]

level.\113\ Gov't Ex. 26 at 17-18. After identifying his handwriting,
the witness [offered testimony that devalued the importance of
documentation]:
---------------------------------------------------------------------------

\113\ The witness testified that the conversation with the
customer-patient led to a resolved understanding of the prescriber's
decision to titrate the customer-patient's medication downward. Tr.
1097.

Q. Dr. Howard, can you please tell the tribunal what was the
intent and purpose of the note that you placed on this particular
prescription?
A. Basically, to document the conversations between the patients
more. With this situation, what occurred is the patient had been in
the hospital for probably about three weeks from a serious infection
and what happened was is [that] the physician reduced the dosage for
the patient based upon her weight loss. So I counseled the patient
and explained to her the reason why the physician reduced her
medication based upon that issue. So that was the reason why I
documented it, it's just an extra compliance step. This is something
that pharmacists do all the time, never to--never to thought to this
point where you would have to do things like this, but this is what
we do.
Q. I'm sorry, when you say you never thought you had to do
things like this, what did you mean by this?
A. Document to this extent. I mean it's just--it's absolutely
absurd because you would be doing more documenting than dispensing
medication if you go by some of the previous testimonies that I've
heard, being a pharmacist.
Q. Let me stop you there. . . .

Tr. 1095-96 (emphasis supplied). When invited multiple times (by the
tribunal and the Respondent's counsel) to explain what he meant about
the documentation being ``absurd,'' the Respondent's owner stuck to his
guns on the issue. Tr. 1098-1100. The owner asked the tribunal whether
he had ever worked in a pharmacy, and upon procuring a negative
response, he offered the following:

Okay. So if you've ever worked in a pharmacy, you have a lot of
patient interaction between yourself and the patient. And you have
conversations every month. If you were to document every
conversation, every incident that you have with a particular
patient, you would not be able to fill prescriptions.

Tr. 1098. When invited again to explain the part of the documentation
obligation that he found ``absurd,'' the Respondent's owner doubled
down, stating:

Well, I mean I think it's absurd to the sense where from
testimony that I've heard, previous testimony that I've heard on you
call a physician every time you almost fill a prescription or if you
know that particular patient, you know their illness. You've had
interaction with that patient over the years. To call a physician,
and you know the physician and you know the patient, on every
prescription is absurd.

Tr. 1099. The only testimony the Respondent's owner ``heard'' during
the hearing on this subject emanated from the Government's expert
witness, but to remove any ambiguity on that front, the witness
clarified that the testimony he was referring to as ``absurd'' was
``the expert witness for the DEA.'' Tr. 1100. Thus, the Respondent's
owner was making it clear that the documentation requirements that
underpin the standard of care are absurd in his view. [Omitted for
brevity. I agree with the Chief ALJ that Respondent's statements as do
not instill confidence in me that he will be compliant with the law in
the future.]
At one point during the witness's testimony, the Government
conducted a voir dire regarding screen shots of RX30 pages (the RX30
Screen Shots) regarding Patient JA that were purportedly generated in
the ordinary course of business in the Respondent pharmacy at the time
of the charged dispensing events.\114\ Resp't Ex. 1(ID) at 55-90.
Although the Government's timeliness objections were overruled, the
Respondent, as the proponent of the evidence,\115\ was ultimately
unsuccessful in bearing its burden to establish admissibility. The
Respondent's theory for admission of the RX30 Screen Shots was founded
on the proposition that each tendered page was a screen shot of
information created and inputted into the RX30 at the time of the
dispensing event. Tr. 664-69. Dr. Howard testified that he created and
prepared every one of the documents within the RX30 Screen Shots. Tr.
669, 686-88. At one point he testified that the data entries were made
either by himself or the pharmacy staff. Tr. 665. He also
(inconsistently) said that he inputted all data into the system
himself. Tr. 688. However, the witness was unequivocal that the screen
shots in question were made by him personally. Tr. 687-88. Yet, when
Dr. Howard was asked to explain, if he truly made all the RX30 entries,
why various RX30 screens contained the initials of pharmacy techs who
work at his pharmacy, his answers were [inconsistent and confusing].
The witness first said that the tech initials could be explained by
``[i]t could've been a different screen that I had to open up, or
something like that.'' Tr. 686. After an offer by Dr. Howard to
``clarify so I can let you understand,'' he explained the presence of
various tech initials by saying, ``That means that when I was logged
into the system, I was logged in under just my initials.'' Id. When
asked why some of the initial fields were blank, the Respondent offered
that this was ``[b]ecause I was logged into my system.'' Tr. 687. When
pressed on this and given another opportunity to explain, the owner
stated that the initials from various pharmacy technicians appeared on
the screens on different pages
---------------------------------------------------------------------------

\114\ As it happens, these documents were not timely served on
the tribunal or the Government, and the Government's timeliness
objections were overruled to afford the Respondent the maximum level
of due process. Tr. 642-60. However, other fundamental issues
regarding foundation and reliability precluded the admission of the
tendered evidence as being sufficiently reliable to be considered in
this adjudication. See 5 U.S.C. 556(d). While the procedural
timeliness objection could be (and was) overlooked by the tribunal
in an effort to ensure the Respondent was able to present its case,
the inherent unreliability of the tendered documents (as discussed,
infra) prevented receipt into the record.
\115\ See 5 U.S.C. 556(d). The untimely filing of the proposed
evidence in the absence of any demonstration of good cause supplied
good cause for the Government's at-hearing authenticity objection.
See 21 CFR 1316.59(c).

[b]ecause I didn't generate them all in one day. I didn't sit there
and go through these all in one day . . . . I just explained to you.
Because when those would generate [sic], it was under that tech's--I
---------------------------------------------------------------------------
guess, that computer.

Tr. 687. Whether the data was all inputted by Dr. Howard (as he said)
or by Dr. Howard and pharmacy staff (which he also said), it is clear
that this is yet another issue upon which Dr. Howard has provided
inconsistent information under oath. Obviously, when taken together,
none of these explanatory statements (made by a highly educated medical
professional) made any sense whatsoever, raising the reasonable
inference that he was being less than candid about the RX30 system, the
identity of those who entered the data, and (most importantly) the
integrity of the proffered evidence.
Although the overwhelming majority of the tendered RX30 Screen
Shots had a ``Print'' option at the bottom of the page, the owner at
one point testified that the pages could not, in fact, be printed. Tr.
672. Dr. Howard then stated that the pages could be printed so long as
the print feature is accessed through the DUR screen related to a
specific dispensing event. Tr. 672. He then reversed himself and
adhered to his initial position that the screen could not be printed
out. Tr. 673.
The majority of these pages contained options for a variety of
actions, to wit: ``F1 Return,'' ``F3 Select,'' ``F5 Print,'' ``F8
Delete,'' and ``F9 Help.'' Resp't Ex. 1(ID) at 57-66, 68-90.
Notwithstanding Dr. Howard's assurance that the pages could not be
printed, the majority of the software pages he tendered for the

[[Page 2925]]

record clearly contained a print option for the operator on the screen.
Page 67 of the RX30 Screen Shots (Page 67) had no option to print, but
unlike any of the other pages, this page had a ``F4 Save'' option,
which was clearly highlighted. Id. at 67. It is not unreasonable to
infer that the appearance of a ``Save'' option that was unique to a
single page signals that as yet unsaved information was entered or
altered into the database and that this changed information is now
amenable to being saved. In the absence of any explanation by the owner
(the purportedly most knowledgeable person at the hearing about the
RX30 system) to the contrary, the preponderant evidence supports the
proposition that Page 67 in the proffered exhibit depicts data that was
altered or supplemented prior to the printing of the page, and not when
the dispensing event occurred. Another feature that was remarkable
about the RX30 Screen Shots is that, notwithstanding the Respondent's
admission theory that these documents represent unadulterated screen
shots that merely and reliably depict information stored in the RX30
system, the cursor is lit up on different fields depending on the page.
Id. at 57, 63, 66, 68-90 (Intervention field), 58-62, 64-65 (Outcome
field), 67 (Reason for Intervention field), 56 (Patient name field), 55
(a listed diagnosis within the International Classification of Diseases
(ICD) field). When asked why the cursor was resting in different fields
depending on the page, the owner dismissively declared that he did not
know, that he had ``no clue,'' that he had ``no idea,'' and that ``[i]f
you're trying to imply that I changed things, you're wrong.'' Tr. 675-
78, 682-83. This was one of the points during the hearing where the
witness's voice and demeanor reflected increasing agitation and volume
as the inquiry progressed.
The witness insisted that he did not know where the cursor
ordinarily populates and was unable to explain why it migrated to
different places on the RX30 Screen Shots.\116\ Tr. 671. Additionally,
when asked why one of the pages contained text that bore a date about
three and a half years beyond the dispensing event date,\117\ the
witness was unable to explain, but just kept repeating that he did not
understand the question, and defensively asked ``what are you trying to
say?'' Tr. 670-71, 679, 681-82.
---------------------------------------------------------------------------

\116\ Notwithstanding his testimony that he inputted all the
information into the RX30 system, the owner did not seem to
understand much about how the system actually works; and his lack of
understanding extended beyond cursors and printing. At another point
in his testimony, Dr. Howard testified that he was unsure if the
customer-patients were presented with counseling screens at the time
of medication dispensing. Tr. 758-59. When asked about it, he simply
said ``I'm not aware of how it works.'' Tr. 758. Ultimately, he gave
up on explaining whether the RX30 had such a feature, and
volunteered that he provides a hardcopy paper counseling election
sheet to each patient. Tr. 759. But when asked where such hardcopy
counseling sheets are maintained at the pharmacy, he was unable to
supply a coherent response. When asked if the counseling sheets are
kept in a binder, his answer was: ``Well, it's not a binder. We keep
it sort of--well, yeah, it's a binder.'' Tr. 760. The same confusion
permeated the owner's testimony about other systems that he would
have been expected to be conversant in. When asked about whether and
where patient questionnaires are maintained and for how long, he
testified that they were stored at the pharmacy, and joked that they
were maintained ``[a]s long as we don't lose them.'' Tr. 601-03.
Inasmuch as he testified that he is the owner, PIC, and exclusive
controlled substance dispensing pharmacist, his general lack of
awareness about the automation system utilized by his pharmacy, and
even other filing systems used there, is surprising. Irrespective of
whether the witness was being intentionally evasive, or genuinely
lacks a basis for understanding the pharmacy systems (automated and
manual) operating under the pharmacy he owns and supervises, this
feature of his presentation was unhelpful in meeting the
Government's evidence.
\117\ Resp't Ex. 1(ID) at 57.
---------------------------------------------------------------------------

Dr. Howard's contradictory and illogical statements, coupled with
his dismissive declarations that he has no clue and no idea about how
his own software system operates and why a host of anomalies were
present in the tendered RX30 Screen Shots, were and are simply
unpersuasive and detracted profoundly, not only from the Respondent's
attempts to secure admission of the evidence, but more fundamentally
from any credibility that could be accorded to the balance of his sworn
testimony.
The dynamic regarding the RX30 notes is rendered worse by the fact
that, as discussed, supra, these purportedly contemporaneously-created
notes fit squarely within the parameters of the DEA's multiple subpoena
demands for:

Gov't Ex. 2 at 1; see Gov't Ex. 18 at 1. The Respondent's owner
[testified that he was confused by what was required]. Tr. 1206-07. The
Respondent's owner is and was a highly-educated, experienced
registrant. The idea that this clear, directive language [was too
confusing for him to comply with the subpoena was not credible].
Similarly unpersuasive was the Respondent's argument that the owner was
unobligated to comply with the Government's multiple subpoenas because
they were addressed to his counsel.\118\ Tr. 1208. The issue here was
not a subpoena enforcement technicality being litigated in a United
States District Court. See 5 U.S.C. 555(d). The Respondent is engaged
in a dangerous, highly-regulated activity, and it and its (then)
counsel well understood the documents the regulator was seeking.
Likewise, the owner's preliminary response to whether he produced the
customer-patient questionnaires that evolved from ``I think, at that
time I think it was [produced], I believe so,'' to a solid declaration
that in the course of several seconds of testimony that he somehow
became sure that the questionnaires were provided, was unconvincing to
say the least. Tr. 1168-73. Similarly, when asked in what format the
questionnaires were supplied to the Government, and if they were
supplied in hard copy, the witness first said, ``I'm not sure. I would
assume. Yeah, they were in hard--well I don't know if they were in hard
copy, but I, I guess they were sent electronically.'' Tr. 1172. This
was shortly followed up by this more definitive declaration:
``Electronically. We produced them electronically.'' Tr. 1173. This was
immediately followed by the following statement:
---------------------------------------------------------------------------

\118\ Tr. 1215.

To be honest with you, I don't 100% know. I know that we
provided them to you. You know, whatever question that you're trying
to get at, I can tell you that we provided them to them, to you. Now
the means that we provided it to you, I cannot remember, so I don't
want to sit here and say something that I did or didn't do, when I
totally don't remember. I can tell you we scanned them. They were in
---------------------------------------------------------------------------
a binder, we scanned them in, and those were provided to you.

Id. [This testimony was inconsistent and not credible. Omitted for
brevity.] The questionnaires and the RX30 notes were not produced when
demanded. They were produced late and with anomalies in the RX30 notes
that precluded a finding that they were reliable and may even possibly
have been altered; and notwithstanding all that, the witness was still
permitted to have his recollections refreshed by mostly reading the
content of the unreliable, untimely-filed documents. The inconsistency
of the owner's

[[Page 2926]]

answers, the structure of the Respondent's actions in subpoena
(non)compliance, and the refreshing use of the documents essentially
precluded reasonable reliance on these late-discovered items and
ultimately hurt the credibility of the Respondent's case.
At another point in the owner's testimony, when asked the basic,
straightforward question as to whether he ``would agree that there are
red flags in pharmacy,'' the witness supplied the following convoluted
response:

Well if you want to deem it as a red flag, if you want to use
the term red flag, that will be considered a red flag, or, if you
check the PMP and you see that this patient that probably has a
valid prescription but they went to two other physicians the day
before, that's a red flag, for the same medication, those--if you
wanna use the term red flag, that's a red flag.

Tr. 1182-83. While the witness did indicate that he would not dispense
a prescription under the scenario his own reply created, his answer was
[concerning in that he remains unwilling to acknowledge the importance,
or even existence, of red flags. He dismissed the concept of a red
flag] as a subjective exercise in whether the questioner (i.e., DEA)
``want[s] to deem it as a red flag,'' whereby anything ``will be
considered a red flag.'' Tr. 1182. [Omitted for brevity. I agree with
the Chief ALJ that these statements do not instill confidence in me
that Respondent will be compliant with the law in the future.]
The Respondent's owner supplied another insightful window into his
true amenability to regulatory oversight at another point in his
testimony. This exchange commenced with an inquiry regarding whether
the questionnaires used by the pharmacy had seen any level of
modification over time. The owner impatiently replied that the
documents were modified in format for ``[t]he same reason why we're
sitting here.'' Tr. 1185. When asked to explain, the witness
[testified]:

All the documentation and things that we try to do to satisfy
the DEA, it still does not matter, all the documentation, all the
compliance that we've done, to show regulatory agencies we go over
and beyond to try to, to make sure that we do our part, it did not
matter. It did not matter. . . . I said it does not matter to the
regulatory agencies. It does not matter as far as how much
compliance the pharmacy does. We [changed the questionnaire] as a
compliance issue to make sure that we're trying to stay in
compliance. We asked for guidance. We try our best to do what's
right.

Tr. 1185-86. Thus, even in this case where the record shows that the
Respondent's documentation was inadequate [and outside the usual course
of professional practice], the owner's response is that he believes he
has done enough and it does not matter what steps his pharmacy takes in
the future. This is not the voice of a registrant seeking to come into
compliance, but essentially one who is communicating that he is
[frustrated] with the efforts already invested to try to meet the state
standards for dispensing controlled substances. The owner's mindset
remained consistent when asked about why the Respondent's patient
questionnaires queried about distance. The witness did not indicate
that distance could be an important red flag of potential diversion,
but rather affirmed that the question was included ``[b]ecause that's
one of the things that the DEA has been targeting, is patients
traveling long distances.'' Tr. 1218. [Omitted for brevity.]
The witness was also unwilling to distance himself from Dr.
Buffington's opinions that DEA has virtually no legitimate role in
regulating the dispensing of controlled substances, notwithstanding
invitations by the tribunal to do so in the best interests of his case.
Tr. 1222-24. [The witness maintained throughout the hearing] that every
single prescription that is the subject of these proceedings was
dispensed correctly and with adequate documentation. Tr. 1224.
On the issue of credibility, Respondent's owner, Dr. Howard, has
the most at stake in these proceedings, as the DEA registration that is
the subject of this litigation concerns his pharmacy. Even beyond that,
the testimony of this witness was often evasive, internally
inconsistent, defensive, implausible, and sometimes even objectively
hostile in tone.\119\ As discussed in considerable detail, supra,
during the course of his testimony, the witness [stated] that many of
the efforts expended in the Respondent's dispensing practices were not
geared toward identifying and targeting potential diversion, but to
avoid professional scrutiny from DEA. [Additionally], the fact that the
Respondent's owner declined to turn over subpoenaed documents until
late in the proceedings, and sponsored documents that raised anomalies
that were fatal to their reception into the record, further undermined
his credibility, resulted in an adverse inference, and diluted the
strength of his case. As discussed, supra, the Respondent's owner
[declined] to distance himself from the testimony of its expert witness
that DEA [does not have a significant role] in regulating pharmacy
practice. To be sure, there were certain historical and/or biographical
features of this witness's testimony that could be credited, but
regrettably, the testimony presented by this witness cannot be afforded
a positive credibility finding.
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\119\ Even beyond the words on the page of a sterile transcript
(quite animated, even on their own in this case), the witness's tone
and volume during his testimony was sometimes elevated and presented
on multiple occasions as impatient and even visibly angry.
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Other facts necessary for a disposition of this case are set forth
in the balance of this recommended decision.

The Analysis

The Government seeks revocation based on its contention that the
Respondent, through its pharmacists and employees, has committed acts
that would render its continued registration inconsistent with the
public interest as provided in 21 U.S.C. 823(f). The gravamen of the
Government's allegations and evidence in this case focus on the
Respondent's alleged (1) dereliction in the exercise of its
corresponding responsibility in dispensing of controlled substance
prescriptions and (2) violations of federal and state laws relating to
controlled substances.

Public Interest Determination: The Standard

Under 21 U.S.C. 824(a)(4), the Agency may revoke the COR of a
registrant if the registrant ``has committed such acts as would render
[its] registration . . . inconsistent with the public interest.'' 21
U.S.C. 824(a)(4). Congress has circumscribed the definition of public
interest in this context by directing consideration of the following
factors:

(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(3) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.

21 U.S.C. 823(f).
``These factors are to be considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). Any one or a combination
of factors may be relied upon, and when exercising authority as an
impartial adjudicator, the Agency may properly give each factor
whatever weight it deems appropriate in

[[Page 2927]]

determining whether a registrant's COR should be revoked. Id.; see
Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005). Moreover, the
Agency is ``not required to make findings as to all of the factors,''
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005) (citing Morall, 412
F.3d at 173-74), and is not required to discuss consideration of each
factor in equal detail, or even every factor in any given level of
detail. Trawick v. DEA, 861 F.2d 72, 76 (4th Cir. 1988) (holding that
the Administrator's obligation to explain the decision rationale may be
satisfied even if only minimal consideration is given to the relevant
factors, and that remand is required only when it is unclear whether
the relevant factors were considered at all). The balancing of the
public interest factors ``is not a contest in which score is kept; the
Agency is not required to mechanically count up the factors and
determine how many favor the Government and how many favor the
registrant. Rather, it is an inquiry which focuses on protecting the
public interest.'' Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009).
In the adjudication of a revocation of a DEA COR, DEA has the
burden of proving that the requirements for the revocation it seeks are
satisfied. 21 CFR 1301.44(e). Where the Government has met this burden
by making a prima facie case for revocation of a registrant's COR, the
burden of production then shifts to the registrant to show that, given
the totality of the facts and circumstances in the record, revoking the
registrant's COR would not be appropriate. Med. Shoppe-Jonesborough, 73
FR 364, 387 (2008). Further, ``to rebut the Government's prima facie
case, [a respondent] is required not only to accept responsibility for
[the established] misconduct, but also to demonstrate what corrective
measures [have been] undertaken to prevent the re-occurrence of similar
acts.'' Jeri Hassman, M.D., 75 FR 8194, 8236 (2010); accord Krishna-
Iyer, 74 FR 464 n.8. In determining whether and to what extent a
sanction is appropriate, consideration must be given to both the
egregiousness of the offense established by the Government's evidence
and the Agency's interest in both specific and general deterrence.
David A. Ruben, M.D., 78 FR 38,363, 38,364, 38385 (2013).
Normal hardships to the registrant, and even the surrounding
community, which are attendant upon lack of registration, are not a
relevant consideration. Heavenly Care Pharmacy, 85 FR 53,402, 53,420
(2020) (principle conclusively applied to pharmacy registrants); Linda
Sue Cheek, M.D., 76 FR 66,972, 66,972-73 (2011); Gregory D. Owens,
D.D.S., 74 FR 36,751, 36,757 (2009). Further, the Agency's conclusion
that ``past performance is the best predictor of future performance''
has been sustained on review in the courts, Alra Labs., Inc. v. DEA, 54
F.3d 450, 452 (7th Cir. 1995), as has the Agency's consistent policy of
strongly weighing whether a registrant who has committed acts
inconsistent with the public interest has accepted responsibility and
demonstrated that future misconduct will not occur. Hoxie, 419 F.3d at
483.\120\
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\120\ The Agency has consistently adhered to this policy in its
adjudications. See, e.g., Ronald Lynch, M.D., 75 FR 78,745, 78,754
(2010) (holding that the respondent's attempts to minimize
misconduct undermined acceptance of responsibility); George Mathew,
M.D., 75 FR 66,138, 66,140, 66,145, 66,148 (2010); George C. Aycock,
M.D., 74 FR 17,529, 17,543 (2009); Krishna-Iyer, 74 FR 463; Steven
M. Abbadessa, D.O., 74 FR 10,077, 10,078 (2009); Med. Shoppe-
Jonesborough, 73 FR 387.
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Although the burden of proof at this administrative hearing is a
preponderance-of-the-evidence standard, see Steadman v. SEC, 450 U.S.
91, 100-03 (1981), the Agency's ultimate factual findings will be
sustained on review to the extent they are supported by ``substantial
evidence,'' Hoxie, 419 F.3d at 481. While ``the possibility of drawing
two inconsistent conclusions from the evidence'' does not limit the
Administrator's ability to find facts on either side of the contested
issues in the case, Shatz v. U.S. Dep't of Justice, 873 F.2d 1089, 1092
(8th Cir. 1989) (citation omitted), all ``important aspect[s] of the
problem,'' such as a respondent's defense or explanation that runs
counter to the Government's evidence, must be considered, Wedgewood
Vill. Pharmacy v. DEA, 509 F.3d 541, 549 (D.C. Cir. 2007); see
Humphreys v. DEA, 96 F.3d 658, 663 (3d Cir. 1996). [Omitted for
brevity.]
[Omitted for brevity.] It is well settled that, because the
Administrative Law Judge has had the opportunity to observe the
demeanor and conduct of hearing witnesses, the factual findings set
forth in this recommended decision are entitled to significant
deference, see Universal Camera Corp. v. NLRB, 340 U.S. 474, 496
(1951), and that this recommended decision constitutes an important
part of the record that must be considered in the Agency's final
decision, see Morall, 412 F.3d at 179. However, any recommendations set
forth herein regarding the exercise of discretion are by no means
binding on the Administrator and do not limit the exercise of that
discretion. See 5 U.S.C. 557(b); River Forest Pharmacy, Inc. v. DEA,
501 F.2d 1202, 1206 (7th Cir. 1974); Attorney General's Manual on the
Administrative Procedure Act Sec. 8(a)(1947).

Factors Two and Four: The Respondent's Experience Dispensing Controlled
Substances

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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.